Service decision and evidence guide

EUDAMED identifier mapping: Basic UDI-DI, UDI-DI and issuing entity

The acquired dictionary identifies a Basic UDI-DI code together with its issuing entity, and a UDI-DI reference back to its Basic UDI-DI. Map these relationships explicitly rather than placing all identifiers in one interchangeable column.

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 taskWhat the source describesWhat to prepare
DD BASIC UDI / FLD-UDID-01 / Issuing Entity Basic UDI-DIDescription: 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: 1 | Updateability: not stated | Referenced rules: not stated | XML mapping: issuingEntityCode [1]Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD BASIC UDI / FLD-UDID-14 / Basic UDI- DI codeDescription: Device Identifier 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 | Occurrence: 1 | Updateability: not stated | Referenced rules: BR-UDID-003 | XML mapping: DICode [2]Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD UDI-DI / FLD-UDID-145 / Basic UDI-DI IdentifierDescription: Reference to the Basic UDI-DI to which the Device is associated. | Occurrence: 1 | Updateability: not stated | Referenced rules: not stated | XML mapping: basicUDIIdentifier [3]Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD UDI-DI / FLD-UDID-291 / Issuing Entity (Master) UDI-DIDescription: 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: 1 | Updateability: not stated | 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.
Acquired dictionary version history2.27.0 [5]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 identifier mapping 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.

  1. Separate identifier levels

    Inventory Basic UDI-DI and device UDI-DI values and issuing entities in distinct source columns.

    Useful evidence: An identifier/issuing-entity inventory reconciled to labels and declarations.

  2. Map the parent relationship

    Link each device identifier to the correct Basic UDI-DI; investigate missing or ambiguous parent assignments.

    Useful evidence: A device-to-Basic-UDI mapping and exception list.

  3. Agree registration versus correction scope

    Have the provider identify which records are new and which existing relationships need a supported correction.

    Useful evidence: A versioned record plan with ownership and acceptance checks.

Work packages and dependencies

Questions for providers

Sources and data dates

Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.

European Commission / Swissmedic — published reference ↗

Thu, 27 Aug 2026 11:33:35 GMT · retrieved 2026-10-07

Audit details: precise locators and snapshot identifiers

Source key D07 · snapshot 6be29f5d393e95dbf5876b1a7c96f871d164111fb85f8eb086472218945c69c5

  • [1] DD BASIC UDI!row 4 / observed dictionary field · record 5fe0c2530059c9949225b0b542119bd14b1153196b57a43c0fd7bd2033614c47
  • [2] DD BASIC UDI!row 5 / observed dictionary field · record 8ecf825175d38ca2389714798e2748322fefc0745fc18aab9d294ae9a86a4f5e
  • [3] DD UDI-DI!row 12 / observed dictionary field · record 7eb91d422db9604fb49cec4edb5b836c7bd6cdea6d1568d758d7e9c5164e82da
  • [4] DD UDI-DI!row 5 / observed dictionary field · record d0647c518f19d17c0d5ff68c9b3f49544909c794973058ed33d643f2b0c3d014
  • [5] Version history!row 7 / version history · record 0104e358d46f4b84ab408953e8e901801bfe675566b0880393e7bb678a8a5487

Prepare an editable project brief

Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.

Choose work packages to discuss

Compare EUDAMED Onboarding & Data Registration Support (Mandatory Modules)

Find EUDAMED Registration| Compare & Get Quotes