EUDAMED unit-of-use and direct-marking identifiers: preserve different meanings
The acquired dictionary distinguishes unit-of-use, direct-marking and device identifiers, with separate issuing-entity fields and conditional descriptions. Do not infer one identifier from another without checking the actual label, marking and unit configuration.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Sourced criteria · EU · EUDAMED
What changes the service scope?
Decision or task
What the source describes
What to prepare
DD UDI-DI / FLD-UDID-135 / Unit of Use DI code
Description: 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 can be provided when the value of the field Direct marking (Is the Device Directly marked) is false and Quantity of Device is more than 1.
Information about the Unit of Use DI can be provided together with the first registration of the Device or at a later stage | Occurrence: 0..1 | Updateability: Y
(Add)
Can be provided later on if initially not provided | Referenced rules: BR-UDID-03, BR-UDID-023 | XML mapping: unitOfUseIdentifier (DIIdentififierType->DIcode) [1]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD UDI-DI / FLD-UDID-292 / Issuing Entity Unit of Use DI
Description: 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')
Issuing Entity for Unit of Use DI can differ from the one of the UDI-DI. | Occurrence: 0..1 | Updateability: Y
(Add)
Can be provided later on if initially not provided | Referenced rules: not stated | XML mapping: issuingEntityCode [2]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD UDI-DI / FLD-UDID-138 / Direct Marking UDI-DI code
Description: 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 ( (Is the Device Directly marked is true). The value of the field is a DI - either the current UDI-DI (of the current device) or a different UDI-DI.
Information about the Direct Marking DI can be provided together with the first registration of the Device or at a later stage | Occurrence: 0..1 | Updateability: Y
(Add)
Can be provided later on if initially not provided | Referenced rules: BR-UDID-03
BR-UDID-639 | XML mapping: directMarkingDI
(DIIdentififierType->DIcode) [3]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD UDI-DI / FLD-UDID-294 / Issuing Entity Direct marking DI
Description: 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'). | Occurrence: 0..1 | Updateability: Y
(Add)
Can be provided later on if initially not provided | Referenced rules: not stated | XML mapping: issuingEntityCode [4]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
Dated technical/help evidence, not a complete legal duty set or live EUDAMED response. Current target-environment release, business rules, permissions and actual buyer records remain unresolved. Blank dictionary flags are unknown; occurrence and update notes keep their stated conditions. No credentials, registration deadline or completed production exchange is inferred.
Prepare the EUDAMED unit-of-use and direct-marking identifiers work package
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Document the supplied unit and marking
Record base-package contents, individual labelling and actual direct marking.
Useful evidence: Label/marking evidence and unit/package configurations.
Map conditional identifiers
Compare the exact unit-of-use and direct-marking descriptions with those facts; retain unresolved conditions.
Useful evidence: An identifier-purpose matrix with separate issuing entities.
Check registration dependencies
Have the provider review current business rules and supported update operations before importing the mapped fields.
Useful evidence: A conditional-field mapping, rule locators and correction/test plan.
Work packages and dependencies
Conditional: EUDAMED unit-of-use and direct-marking identifiers: preserve different meanings — Review the actual current records and target-environment requirements; complete the specific mapping/onboarding or maintenance task with source/version and acceptance evidence.
Optional: Related preparation or maintenance support — Use only where the mapped records require that additional phase; confirm ownership and deliverables before adding this service.
Questions for providers
How will you resolve the specific field/identity or state dependencies shown here for our actual records?
Which current environment release, permissions and business rules support the proposed operation?
What mapping, unresolved-error and acceptance evidence will you hand over, and who owns each correction?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
