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Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System
EUDAMEDClass I (EU MDR)
Ref ODB-01
Identity
- Trade Name
- Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System EUDAMED
- Device Name
- Surgical Instrument EUDAMED
- Model / Reference
- ODB-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809399745958 EUDAMED
- Basic UDI-DI
- B-08809399745958 EUDAMED
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System by OSTEONIC CO., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08809399745958 | Class I | Active |
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Manufacturer
- Manufacturer
- OSTEONIC Co., Ltd.
- EUDAMED SRN
- KR-MF-000008969
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 9b6d97b3-097c-471b-af3a-d76c137c600e 61 fields · synced Jun 18, 2026