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Disposable Powered Articulating Endoscopic Linear Cutter Stapler
EUDAMEDClass IIa (EU MDR)
Ref FH13Model FSM Series, FNM Series
Identity
- Trade Name
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler EUDAMED
- Device Name
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler EUDAMED
- Model / Reference
- FSM Series, FNM Series EUDAMEDFH13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921348308426 EUDAMED
- Basic UDI-DI
- 69213483FH1301E5D EUDAMED
- EMDN Code
- H020301050199 SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Disposable Powered Articulating Endoscopic Linear Cutter Stapler by Fengh Medical Co., Ltd. — Class IIa — 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 | 69213483FH1301E5D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fengh Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000004718
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 40a1c52b-49b9-4eb0-99f2-aa9b907e482f 61 fields · synced Jun 18, 2026