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Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System
EUDAMEDClass I (EU MDR)
Ref TPO-006
Identity
- Trade Name
- Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System EUDAMED
- Device Name
- Surgical Instrument EUDAMED
- Model / Reference
- TPO-006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809416063850 EUDAMED
- Basic UDI-DI
- B-08809416063850 EUDAMED
- EMDN Code
- S010499 STERILISATION CONTAINERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Our Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System is designed for surgeons to facilitate safe and precise surgical procedures. This advanced instrument features a robust design, precision engineering, and high-quality materials to ensure accurate fixation of the cranio-maxillofacial complex.
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-08809416063850 | 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 30f54353-e5f2-4a6c-85cb-66371afe6ff1 61 fields · synced Jul 22, 2026