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FWS-WJ-008A ballon
EUDAMEDClass IIa (EU MDR)
Ref -Model FWS-WJ-008A ballon (sterile)
Identity
- Trade Name
- FWS-WJ-008A ballon EUDAMED
- Device Name
- Vertebroplasty auxiliary instrument EUDAMED
- Model / Reference
- FWS-WJ-008A ballon (sterile) EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-008A/BPW EUDAMED
- Basic UDI-DI
- B-008A/BPW EUDAMED
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIa 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
FWS-WJ-008A ballon by Chongqing FWS Medical Device Co., Ltd — Class IIa — 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-008A/BPW | Class IIa | 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 ea5e9190-56eb-4e45-838d-def262d1bb41 61 fields · synced Jul 19, 2026