EUDAMED container packages: quantities, child links and status dependencies
The acquired package dictionary describes a hierarchy that closes at the device UDI-DI, with package identifier/issuing entity, quantity and child relationships when a container package is supplied. Prepare a tree rather than an unstructured list of package codes.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
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: 1
Occurrence applicable if Container Package (FLD-UDID-309 is provided | 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 Container Pack / FLD-UDID-120 / Package UDI-DI
Description: Unique identifier of the Package UDI-DI. | Occurrence: 1
Occurrence applicable if Container Package (FLD-UDID-309 is provided | Updateability: not stated | Referenced rules: BR-UDID-03 | XML mapping: identifier [2]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD Container Pack / FLD-UDID-121 / Quantity per package
Description: Number of Items in the Package Structure.
Used when describing the Container Packaging Structure of a Device. | Occurrence: 1
Occurrence applicable if Container Package (FLD-UDID-309 is provided | Updateability: not stated | Referenced rules: not stated | XML mapping: numberOfItems [3]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD Container Pack / FLD-UDID-124 / Related Package (/ UDI-DI)
Description: Container Packaging Structure is a hierarchical structure defining how the Device is packaged together for shipping and selling reasons.
The definition of the structure can start from the highest element in the structure (highest package in the structure) which contains no more parents and continues till the UDI-DI. Each element in the structure (each package element) must be defined.
For all structures defined, the last element (lowest element in the structure) defined must be the UDI-DI (all structures defined - if several are defined, must be closed with the UDI-DI).
The field stores a link to the child element in the structure (current element being its parent). Field will not be provided for the lowest element - the UDI-DI (as it has no more childs) | Occurrence: 1
Occurrence applicable if Container Package (FLD-UDID-309 is provided | Updateability: not stated | Referenced rules: BR-UDID-661 | XML mapping: child [4]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD Container Pack / FLD-UDID-130 / Container Pack Status
Description: Status of the Container Package element (On the EU market, Not intended to be placed on the EU market, No longer placed on the EU market) | Occurrence: 1
Occurrence applicable if Container Package (FLD-UDID-309 is provided | Updateability: Y
(Edit)
Only when the device is On the EU market status | Referenced rules: BR-UDID-073 | XML mapping: code [5]
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 container packages 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.
Draw each actual package chain
Start with the real packaging structure and identify the device UDI-DI at the end of each chain; flag orphan or cyclic links.
Useful evidence: A package hierarchy with each parent/child relationship.
Reconcile identifiers and quantities
Record each package DI, issuing entity and quantity with the corresponding source evidence.
Useful evidence: A package-level identifier/quantity worksheet.
Plan changes and status reconciliation
Ask which existing package/status records need amendment and how changed hierarchy data will be checked.
Useful evidence: A before/after tree, status plan and mapping-validation results.
Work packages and dependencies
Conditional: EUDAMED container packages: quantities, child links and status dependencies — 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.
