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Disposable Endoscopic Linear Cutter Stapler
EUDAMEDClass IIa (EU MDR)
Ref FH01Model DA Series, DR Series
Identity
- Trade Name
- Disposable Endoscopic Linear Cutter Stapler EUDAMED
- Device Name
- Disposable Endoscopic Linear Cutter Stapler EUDAMED
- Model / Reference
- DA Series, DR Series EUDAMEDFH01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921348306767 EUDAMED
- Basic UDI-DI
- 69213483FH0102R5H EUDAMED
- EMDN Code
- H02030199 LINEAR STAPLERS 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 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 | 69213483FH0102R5H | 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 266d1f7e-853e-4fb3-9a13-469a04f21b3f 61 fields · synced Jun 19, 2026