Données Eudamed associées aux IUD (dispositifs & systèmes et nécessaires)
Deux nouveaux documents relatif à Eudamed (et à l’IUD) sont disponibles sur le site de la commission.
Le premier document est un – gros – tableur donnant un aperçu des données qui doivent être fournies à Eudamed.
Le document présente les différents attributs, selon leur association avec les différents IUD (IUD de base et IUD-ID, en général et pour les systèmes et nécessaires). Les champs et les règles utiles aux entités d’attribution sont également définis. Ce document est très technique et ne sera pas très utile aux utilisateurs.
Le second document est une infographie / un résumé du principe d’héritage des données saisies dans Eudamed, selon les IUD.
Pour rappel :
- L’IUD de base est le principal identifiant d’un dispositif, il identifie son modèle.
- L’IUD-ID complète l’IUD de base, il ne change qu’en cas de modification majeure du dispositif.
- Les systèmes et nécessaires doivent avoir leur propre IUD (voir le guide du MDCG).
Résumé
Les paragraphes suivants présentent différents attributs de la base de données Eudamed, en fonction de leur association aux différents IUD.
Les informations sont extraites du tableau fourni par la commission, elles sont en anglais. Pour chaque attribut, les tableaux reprennent l’ID, le titre et la description.
Attributs communs
Ces attributs d’Eudamed sont associés aux IUD de base et aux IUD-ID, pour les dispositifs et pour les systèmes et nécessaires :
| FLD-UDID-01 | Issuing Entity | Assigned Issuing Entities that will generate the DI Codes allocated for all DI`s inside Eudamed (Basic UDI DI, UDI-DI, Unit of Use DI, Secondary Di , Package level DI). The Commission shall designate one or several entities to operate a system for assignment of UDIs (‘issuing entity’) |
| FLD-UDID-02 | Basic UDI- DI Value / UDI-DI Code/ Package UDI-DI Code. Secondary DI. Unit of Use DI | Device Identified code/value (DI Code). Together with the Issuing Entity creates the uniqness of the element to which they are assigned (Basic UDI-DI , UDI-DI, etc.) The Basic UDI-DI is the primary identifier of a device model.It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database. The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together. Direct Marking UDI-DI – is the DI with which the Device (UDI-DI) is labeled directly |
| FLD-UDID-95 | Version Date | In order to keep a referens to the changes performed in the different system entities, a version control mechanism is set up in place. Property stores the Date when the version was last updated |
| FLD-UDID-98 | Version Number | In order to keep a referens to the changes performed in the different system entities, a version control mechanism is set up in place. Property stores the Number of the Version when the version was last updated |
| FLD-UDID-99 | State | In order to keep a referens to the changes performed in the different system entities, a version control mechanism is set up in place. Property stores the State of the Version |
Attributs associés à l’IUD de base
Des informations “haut niveau” sont associées aux IUD de base :
| FLD-UDID-16 | Risk Class | Risk Class of the Device associated with the Basic UDI-DI. Device Risk Class is dependent directly on the Applicable Legislation of the Device. |
| FLD-UDID-20 | Device Model | I nformation allowing the identification of the device – Device Model. At least one of the Device identification details (Device Model or the Device Name) have to be provided for a Basic UDI-DI. |
| FLD-UDID-22 | Device Name | I nformation allowing the identification of the device – Device Name. At least one of the Device identification details (Device Model or the Device Name) have to be provided for a Basic UDI-DI. |
Attributs uniquement associés à l’IUD de base des dispositifs
| FLD-UDID-10 | Manufacturer SRN | SRN of the Manufacturer that registers the Device. |
| FLD-UDID-11 | Applicable Legislation | Applicable Legislation of the Device. The device can have only one Applicable Legislation. Either a Regulation value can be selected/provided (MDR or IVDR) or a Directive Regulation value (MDD, AIMDD or IVDD) – in the case of Directive Devices. |
| FLD-UDID-12 | Is it a System which is a Device in itself, Procedure pack which is a Device in itself or Kit | Property defines if the Basic UDI-DI is refering to a System which is a Device in itself, Procedure pack which is a Device in itself or Kit. Property is a applicable for Standard Devices (not Systems or Procedure Packs) |
| FLD-UDID-13 | Special Device Type | Property defines if the Device is a Special Device Type anf if so , the type of Special device Type. In case the Device is a Standard Device having the option System or Procedure Pack (which is a Device in itself) or a System or Procedure Pack – field is not supplied. |
| FLD-UDID-15 | Authorised Representative | The SRN of the Authorised Representative associated with the Basic UDI-DI. For Manufacturers which are not established in the Union (NonEU Manufacturers) providing the Authorised Representative for the Basic UDI-DI is required. |
| FLD-UDID-18 | Tissues and cells – Presence of animal tissues or Cells, or their derivates | Property defines if the Device has presence of animal tissues or cells or their derivates |
| FLD-UDID-23 | Tissues and cells – presence of human tissues or cells, or their derivates | Property defines if the Device has presence of human tissues or cells or their derivates |
| FLD-UDID-28 | Active Device | Property defines if the Basic UDI-DI corresponds to an Active device or not. ‘Active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device. |
| FLD-UDID-29 | Device Intended to administer and/or Remove medicinal product | Property defines if the Device is intended to administer or remove medicinal product |
| FLD-UDID-30 | Implantable | Property defines if the Basic UDI-DI corresponds to a device that is Implantable or not. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device |
| FLD-UDID-31 | Measuring Function | Property defines if the Device has a Measuring Function or not |
| FLD-UDID-32 | Reusable Surgical Instruments | Property defines if the Device is a Reusable Surgical Instrument or not. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the Manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. |
| FLD-UDID-33 | Companion Diagnostic | Property defines if the Device corresponds to a device that has a role of Companion Diagnostic device or not. ‘Companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to: – identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or – identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product. |
| FLD-UDID-34 | Tissues and cells – Presence of cells or substances of microbial origin | Property defines if the Device contains presence of substances of microbial origin |
| FLD-UDID-35 | Near Patient Testing | Property defines if the Device device is Near Patient testing or not. ‘Device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional; |
| FLD-UDID-36 | Patient Self Testing | Property defines if the Device is Self Patient testing device or not. ‘Device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services; |
| FLD-UDID-51 | Clinical Investigation reference Number | When registering the Device – where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation must be provided. Field stores the Clinical Investigation Number provided by the user when the Clinical Investigation is not registered in EUDAMED |
| FLD-UDID-60 | Certificate Type (Technical Documentation, Type Examination, etc) | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property defines the type of Product Certificate associate with the Device. |
| FLD-UDID-61 | Certificate Number | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the Certificate Number of the Product Certificate |
| FLD-UDID-62 | Revision Number | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the Certificate Revision Number of the Product Certificate |
| FLD-UDID-63 | Notified Body | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the reference to the Notified Body that issued the Product Certificate |
| FLD-UDID-64 | Expiry Date | When registering the Device, for Devices covered by Product certificates, user will have to provide identification details of the Product Certificate covering the Device. Property stores the Certificate Expiry Date of the Product Certificate |
| FLD-UDID-155 | Presence of a substance which , if used separately, may be considered to be a medicinal product derived from human blood or plasma | Defines if the Device containes substances which may be considered medicinal product derived from human blood or plasma |
| FLD-UDID-158 | Presence of substance which, if used separately, may be considered to be a medicinal product | Defines if the Device containes substances which may be considered medicinal product |
| FLD-UDID-262 | Reagent | Property defines if the Device is a reagent or not. |
| FLD-UDID-263 | Professional Testing | Property defines if the Device is designed to be used for Professional Testing or not. |
| FLD-UDID-264 | Instrument | Property defines if the Device is an Instrument or not. |
| FLD-UDID-265 | Is it Device a suture, staple, dental filling, dental brace (…)? | Property defines if the registered Device is ‘suture’, ‘staple’ , ‘dental filling’ etc. Property is applicable only for Devices having Risk Class II b and having the property ‘Implantable’ marked |
Attributs uniquement associés à l’IUD de base des systèmes et nécessaires
| FLD-UDID-44 | System or Procedure Pack Producer SRN | SRN of the System or Proceudre Pack Producers that registers the System or Procedure Pack. |
| FLD-UDID-260 | Medical Purpose of the Device | Description of the Medical Purpose of the System or Procedure Pack. Field is applicable for System and Procedure Packs and refers to the Indication of the specific medical purpose of the System or Procedure Pack Producer |
| FLD-UDID-261 | Type of System or Procedure Pack | Type of the System or Procedure Pack |
Attributs associés aux IUD-ID
| FLD-UDID-121 | Quantity per package | Number of Items in the Package Structure. Used when describing the Container Packaging Structure of a Device. |
| FLD-UDID-122 | Recall Precision | When the Status of a Device is set to FSCA Initiated or Recall, details about the Scope of the Recall/ FSCA are required (description of the serialnumber / lot number, etc.) Field stores the details of the recalled elements (batch numbers, lots numbers , etc.) of the Device – when the Scope of Recalled is entered manually by the user (not by referencing an FSN) |
| FLD-UDID-123 | Scope of Recall | When the Status of a Device is set to FSCA Initiated or Recall, details about the Scope of the Recall/ FSCA are required (description of the serialnumber / lot number, etc.) Field defines how the Scope of the Recall is defined (by Lot number, Serial Number , etc.) |
| FLD-UDID-124 | Container Packaging Structure is a ierarhical structure defining how the Device is packaged together for shipping and selling reasons. The basic (the lower) element of the Packagining Structure is the UDI-DI. The field stores a link to previous element in the Package Structure (parent element) |
|
| FLD-UDID-130 | Device Status | Status of the Device (On the market, No longer placed on the market). |
| FLD-UDID-131 | Device SubStatus | SubStatus of the Device (Recalled, Field safety corrective action initiated) |
| FLD-UDID-136 | Secondary UDI – DI value | Secondary UDI DI Code – reference to the Secondary UDI-DI registered for the current UDI-DI . Additional DI associated to this UDI-DI. Only one Secondary UDI-DI (Additional UDI-DI) can be associated to a UDI-DI |
| FLD-UDID-145 | Basic UDI-DI Identifier | Reference to the Basic UDI-DI to which the Device is associated. |
| FLD-UDID-148 | Type of UDI-PI | Reference to the Types of UDI-PI (production Identifiers) applicable for the current Device (UDI-DI). Defines the way the production is controled |
| FLD-UDID-149 | Nomenclature code | The Device Nomenclature Code(s) associated with the UDI-DI. The corresponding CND Nomenclature Code will be stored in the field Only one Nomenclature Code can be associated to the UDI-DI. |
| FLD-UDID-163 | Reference / Catalogue Number | Property stores the Reference or Catalogue Number of the Device |
| FLD-UDID-169 | Device labelled sterile | Property defines if the UDI-DI is labeled as Sterile or not |
| FLD-UDID-170 | Need for sterilisation before use | Property defines if the UDI-DI needs to be sterilised before use or not |
| FLD-UDID-174 | URL for additional information | Manufacturer`s website where additional information about the device (UDI-DI) are available |
| FLD-UDID-175 | Additional product Description | Additional Product Description. Additional Product Description is required for System or Procedure Packs or for Standard Devices being marked as System or Procedure Packs (as a Device in themselvs) |
| FLD-UDID-176 | Name/ Trade name | Device Trade Name assigned to the UDI-DI Trade names can be provided if applicable for the device. Several Trade- Names can be provided for the Device in the same language or in different languages. |
| FLD-UDID-210 | ? | Storage and handling Conditions and Critical Warnings or Contra-Indications specified on the Label of the Device or in the Instruction of Use have to be registered in EUDAMED – if applicable. Field stores the type of Instruction for use (possible values Critical Warnings or Storage and Handling Conditions) |
| FLD-UDID-211 | Storage/handling conditions type | Storage and handling Conditions and Critical Warnings or Contra-Indications specified on the Label of the Device or in the Instruction of Use have to be registered in EUDAMED – if applicable. Field stores the Type of Storage and Handling Conditions. Field is Applicable only when the type of Conditions for Use have the Type Storage / handling Conditions, being required in this case. |
| FLD-UDID-212 | Critical Warnings type | Storage and handling Conditions and Critical Warnings or Contra-Indications specified on the Label of the Device or in the Instruction of Use have to be registered in EUDAMED – if applicable. Field stores the Type of Critical Warnings or Contra-Indications, being required in this case. |
| FLD-UDID-213 | Storage/Handling conditions / Critical warnings or contra-indications | Storage and handling Conditions and Critical Warnings or Contra-Indications specified on the Label of the Device or in the Instruction of Use have to be registered in EUDAMED – if applicable. Comments or description associated to the values selected form the Storage or handling Conditions or Critical warnings |
Attributs uniquement associés à l’IUD-ID des dispositifs
| ? | /Date of Status / Substatus update | Date when the Status/ Substatus is updated |
| FLD-UDID-135 | Unit of Use DI | Unit of Use DI – reference to the Unit of Use DI applicable for the current UDI-DI (Device Identifier). A virtual identifier assigned to an individual medical device when a Unique Device Identifier (UDI) is not labeled on the individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient when a base package contains more than one device. Field is mandatory when the value of the field Direct marking is false and Quantity of Device is more than 1. |
| FLD-UDID-137 | Member State of the placing on the EU market of the device | Defines the Country were the device has been placed on the Market (Member State in which the device is to or has been placed on the market in the Union) |
| FLD-UDID-138 | Direct Marking UDI-DI | Direct Marking UDI-DI – is the DI with which the Device (UDI-DI) is marked directly Field is mandatory when the Device is directly marked ( Direct Marking = YES). The value of the field is a DI – either the current UDI-DI (of the current device) or a different UDI-DI. |
| FLD-UDID-147 | Intended purpose other than medical (Annex XVI) | Field stores the reference to the Intended purpose other than medical of the Device (UDI-DI). Field stores the values regarding the Intended purpose of the Device other the medical one`s as they are descubed in the Annex XVI of MDR Regulation. |
| FLD-UDID-151 | Quantity of Device | The base quantity in which the Device is provided. Field has a default value 1. |
| FLD-UDID-153 | Is the Device directly marked? | Property defines if the Device is directly marked with a DI Code or not (is not labelled individually) |
| FLD-UDID-156 | Containing latex | Property defines if the Device contains latex into it`s composition |
| FLD-UDID-157 | Maximum number of reuses | Property defines the Maximum Number of reuses applicable for the Device. Field is optional and can be completed if the Device is not marked as single use device ( singleUse is false). |
| FLD-UDID-159 | New Device | Defines if the Device can be considered a ‘New’ Device or not. A device shall be considered to be ‘new’ if: (a) there has been no such device continuously available on the Union market during the previous three years for the relevant analyte or other parameter; (b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Union market during the previous three years. |
| FLD-UDID-160 | Not intended for being placed on the EU market | Property defines if the the device is not intended to be placed on the EU market or Not. If submitted with value True, Device is not considered as intended for EU Market. In case the field is submitted with value True, values for fields ‘Member State were the Device is placed on the Market’ and ‘Member state were the device is made available in the market’ should not be submitted |
| FLD-UDID-164 | Reprocessesed single use device | Property defines if the Device is a Reprocessesed single use device or not |
| FLD-UDID-167 | Labelled as single use | Property defines if the Device is a Labelled as a Single use or not |
| FLD-UDID-190 | /Clinical Size Type | Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit The Type of Clinical Size (example : length, width, etc.) |
| FLD-UDID-191 | /Precizion | Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit Clinical Size Precision – mentions how the recording of Data will be performed (as value, range or Other is selected) |
| FLD-UDID-192 | /Maximum | Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit Maximum Value that the Clinical Size can get (when Range is selected as precision) |
| FLD-UDID-193 | /Value(Minimum) | Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit Value (Minimum) that the Clinical Size can get (when Value or Range is selected as precision) |
| FLD-UDID-194 | /Value(Text) | Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit Value that the Clinical Size can get (when Other is selected as precision) |
| FLD-UDID-195 | /Measure Unit | Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will be defined by the Type, Precizion, Value (either Range, single value or Text) and Measuring Unit Clinical Size Measure Unit |
| FLD-UDID-196 | Labeled for presence of substances being CMR of category 1A or 1B / Labeled for presence of substances having endocrine-disrupting properties/ Presence of a substance which, if used separately, may be considered to be a medicinal product/ Presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma | When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances Field stores the details regatrding the type of Substance registered (CMR Substance / Endocrine substance/ Substance which can be considered a Medicinal Product or Substance which may be considered a medicinal product derived from human blood or plasma) |
| FLD-UDID-200 | Category of CMR | When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances Field stores the Type of CMR Substance. It is only applicable when the Substance registered is a CMR Substance |
| FLD-UDID-201 | Name of Substance | When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances Field stores the Name of Substance (applicable for all types of substances – CMR, Endocrine , Medicinal product, Medicinal product derived from human blood or human). In case of CMR Substances or Medicinal product and Medicinal product derived from human blood or human plasma , if the #CAS or #EC or INN is provided, field is no longer required |
| FLD-UDID-202 | CAS# | When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances Field stores the CAS Code (CAS#) associated to the CMR or Endocrine disrupting substance. CAS# can be provided only for CMR or Endocrine-disrupting substances |
| FLD-UDID-203 | EC# | When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances Field Stores the EC Code (EC#)associated to the CMR or Endocrine disrupting substance. EC# can be provided only for CMR or Endocrine-disrupting substances |
| FLD-UDID-204 | INN | When registering a new Device containing in its composition substances (substances being CMR of category 1A or 1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma), Manufacturer will have to submit the details of those substances Field stores the INN value for the substance provided. INN can be provided only for CMR or Endocrine-disrupting substances which, if used separately, may be considered to be a medicinal product or substances which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma. |
| FLD-UDID-221 | Enter the SRN (Is the Device designed or Manufactured by another legal or natural person) | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. An original design manufacturer (ODM) is a company that designs and manufactures a product, as specified, that is eventually rebranded by another firm for sale. Details of the Product Designer can be given either by providing the SRN (if the PD is already registered in EUDAMED and has an SRN) or by providing Organisation details (Name and Contact Details – in case the PD is not registered in EUDAMED) SRN of the natural or legal person who designed and manufactured the device. Reference to a Manufacturer present in EUDAMED |
| FLD-UDID-222 | ? | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Reference to an Organisation details provided in case the Manufacturer that designed and manufactured the device is not present in EUDAMED. |
| FLD-UDID-225 | Name | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Field stores the Name of the Organisation (Manufacturer) that designed and manufactured the Device (UDI-DI). Required in case the PD Organisation link is provided (ProductDesignerLink relates to an Organisation) |
| FLD-UDID-230 | Street | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Field stores the Street Name Required in case the PD Organisation link is provided (ProductDesignerLink relates to an Organisation) |
| FLD-UDID-231 | Street number | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Field stores the Street Number Required in case the PD Organisation link is provided (ProductDesignerLink relates to an Organisation) |
| FLD-UDID-232 | Address complement | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Field stores the Complement of the Address (Additional adress details) Required in case the PD Organisation link is provided (ProductDesignerLink relates to an Organisation) |
| FLD-UDID-233 | PO box | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Field stores the POBox Required in case the PD Organisation link is provided (ProductDesignerLink relates to an Organisation) |
| FLD-UDID-234 | City name | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Field stores the City name Required in case the PD Organisation link is provided (ProductDesignerLink relates to an Organisation) |
| FLD-UDID-235 | Postal code | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Field stores the Postal code Required in case the PD Organisation link is provided (ProductDesignerLink relates to an Organisation) |
| FLD-UDID-236 | Country | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Field stores the Country Required in case the PD Organisation link is provided (ProductDesignerLink relates to an Organisation) |
| FLD-UDID-240 | Telephone | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Field stores the Phone Number of the Company Required in case the PD Organisation link is provided (ProductDesignerLink relates to an Organisation) |
| FLD-UDID-241 | Details of the Product Designer (Original Manufacturer) who Manufactured (produced) or Designed the Device. Field stores the Email of the Company Required in case the PD Organisation link is provided (ProductDesignerLink relates to an Organisation) |
|
| FLD-UDID-250 | Start date | Details regarding the Countries were the Device (UDI-DI) is made available on the market. There can be a Start Date (optional) and an End Date (also optional) of making available on a specific market the product. Field stores details about the Start Date when the Device is made available on the marked |
| FLD-UDID-251 | End date | Details regarding the Countries were the Device (UDI-DI) is made available on the market. There can be a Start Date (optional) and an End Date (also optional) of making available on a specific market the product. Field stores details about the End Date when the Device is made available on the marked |
| FLD-UDID-252 | Member State were the device is or is to be made available | Details regarding the Countries were the Device (UDI-DI) is made available on the market. There can be a Start Date (optional) and an End Date (also optional) of making available on a specific market the product. Field stores details about the Country were the Device is made available on the market |
source : europa.eu
1 commentaire