Identity
- Trade Name
- IVOM-Set EUDAMED
- Device Name
- OP-Set EUDAMED
- Model / Reference
- 91323001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251480309060 EUDAMED
- Basic UDI-DI
- 42514803049L3 EUDAMED
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Kundenindividuelle Zusammenstellung verschiedener CE-gekennzeichneter Einweg-Medizinprodukte, die für einen speziellen Eingriff im OP benötigt werden, steril in einer einzigen Verpackung. Ein individuell zusammengestelltes OP-Set ist nicht für verschiedene Anwender gedacht. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: General internal orthopaedic fixation system implantation kit
IVOM-Set by biocon Medizintechnik GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42514803049L3 | Class I | Active |
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Manufacturer
- Manufacturer
- biocon Medizintechnik GmbH
- EUDAMED SRN
- DE-PR-000019552
Sources (1)
- EUDAMED 99fd5f97-e6cd-4670-9291-2de6bfdab9df 61 fields · synced Oct 6, 2026