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Disposable Powered Articulating Endoscopic Linear Cutter Stapler
EUDAMEDClass IIa (EU MDR)
Ref FH13Model FSA Series, FNA SeriesModel FSM Series, FNM SeriesModel DSA Series, DNA Series
Identity
- Trade Name
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler EUDAMEDDisposable Powered Articulating Endoscopic Linear Cutter Staplers EUDAMED
- Device Name
- Disposable Powered Articulating Endoscopic Linear Cutter Staplers EUDAMED
- Model / Reference
- FSA Series, FNA Series EUDAMEDFH13 EUDAMEDFSM Series, FNM Series EUDAMEDDSA Series, DNA Series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921348308518 EUDAMED06921348308242 EUDAMED06921348308334 EUDAMED06921348308709 EUDAMED
- Basic UDI-DI
- 69213483FH1302E5G EUDAMED69213483FH1301R67 EUDAMED69213483FH1302R6A EUDAMED69213483FH1304E5N EUDAMED
- EMDN Code
- H020301050199 SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY – OTHER EUDAMEDH020301050299 SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITHOUT 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 | 69213483FH1302E5G | 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 (4)
- EUDAMED d7cc59da-e2fb-4f5f-b491-90d4208be30b 61 fields · synced Jul 16, 2026
- EUDAMED 26157f7d-dbd9-4518-9a01-b4bcf1d20459 61 fields · synced May 19, 2026
- EUDAMED 516fd86c-6062-4d29-aa74-1c62cfada35a 61 fields · synced May 19, 2026
- EUDAMED 400ad6de-3630-436e-8b94-f5afceda65c8 61 fields · synced Jul 16, 2026