EUDAMED reuse data: single-use label and maximum-reuse condition
The acquired UDI-DI dictionary makes the maximum-reuse field conditional on a non-single-use device and describes it as optional in that context. Reconcile intended use and labelling before populating it; a numerical reuse entry is not validation of reprocessing.
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-167 / Labelled as single use
Description: Property defines if the Device is a Labelled as a Single use or not | Occurrence: 1 | Updateability: not stated | Referenced rules: not stated | XML mapping: provided through numberOfReuses
If value provided is 0 for numberOfReuses, Device is considered as Single use Device
If value provided is <>0 numberOfReuses (-1 or any value > 0), Device is considered as not being Single use Device [1]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD UDI-DI / FLD-UDID-157 / Maximum number of reuses
Description: 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 ( Single Use Device has value false).
| Occurrence: 0..1
Field must be completed only if singleUse is false | Updateability: not stated | Referenced rules: BR-UDID-24 | XML mapping: numberOfReuses
If value provided is '-1', device is considered as non Single Use Device and the device does not have a maximum number of reuses (infinite number of reuses)
If value provided is '0', devices is considered as Single use Device
If value provided is >1, devices is considered as non Single use Device having a limited number of reuses (the value provided) [2]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
DD UDI-DI / FLD-UDID-164 / Reprocessed single use device
Description: Property defines if the Device is a Reprocessesed single use device or not | Occurrence: 1 | Updateability: not stated | Referenced rules: not stated | XML mapping: reprocessed [3]
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 reuse data 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.
Confirm the labelled use model
Record the actual single-use label, reusable configurations and any reprocessed-single-use context separately.
Useful evidence: Current labels/instructions and presentation-level intended-use facts.
Check the reuse-field condition
Compare the optional maximum-reuse field with the recorded single-use condition and current rules; retain unknown values rather than inventing a count.
Useful evidence: A reviewed conditional mapping and unresolved-limit list.
Reconcile the existing records
Ask which registration corrections are supported and what separate validation evidence underlies any claimed reusable life.
Useful evidence: A correction scope and evidence references for any reuse claim.
Work packages and dependencies
Conditional: EUDAMED reuse data: single-use label and maximum-reuse condition — 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.
