Identity
- Model / Reference
- 10025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060464140259 EUDAMED
- Basic UDI-DI
- B-05060464140259 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Joint prosthesis implantation kit, single-use
10025 by Innovate Orthopaedics — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060464140259 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Innovate Orthopaedics
- EUDAMED SRN
- GB-MF-000012886
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 15bd6c13-5869-48c6-b16b-79cc56ab0ce1 61 fields · synced Jun 18, 2026