Identity
- Trade Name
- Osteotome - 12mm Curved EUDAMED
- Device Name
- Orthopaedic Surgery Osteotomes EUDAMED
- Model / Reference
- 08-12-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032982020481 EUDAMED
- Basic UDI-DI
- 5032982/INSLOST04/4P EUDAMED
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Osteotome - 12mm Curved by JRI Orthopaedics Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 5032982/INSLOST04/4P | Class I | Active |
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Manufacturer
- Manufacturer
- JRI Orthopaedics Ltd
- EUDAMED SRN
- GB-MF-000007529
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 55b26f8b-5302-4250-8cb2-2a8ecf1aa79b 61 fields · synced Jul 21, 2026