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Half-ring Frame (In no) FE8M-H020-WJ (sterile)
EUDAMEDClass IIb (EU MDR)
Ref N/AModel Half-ring Frame (In no) FE8M-H020-WJ (sterile)
Identity
- Trade Name
- Half-ring Frame (In no) FE8M-H020-WJ (sterile) EUDAMED
- Device Name
- Orthopedic external fixation system (with needle） EUDAMED
- Model / Reference
- Half-ring Frame (In no) FE8M-H020-WJ (sterile) EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FE8M/H020WJSGA EUDAMED
- Basic UDI-DI
- B-FE8M/H020WJSGA EUDAMED
- EMDN Code
- P09120499 EXTERNAL BONE FIXATION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Half-ring Frame (In no) FE8M-H020-WJ (sterile) by Chongqing FWS Medical Device Co., Ltd — Class IIb — 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-FE8M/H020WJSGA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Chongqing FWS Medical Device Co., Ltd
- EUDAMED SRN
- CN-MF-000008972
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 3e20940d-e666-44dd-9472-44fa2321cfb7 61 fields · synced Jun 19, 2026