Identity
- Trade Name
- Disposable Endoscopic Stapler Reload Unit EUDAMED
- Device Name
- Disposable Endoscopic Stapler Reload Units EUDAMED
- Model / Reference
- MANUAL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767871575 EUDAMED
- Basic UDI-DI
- 69717687MANUAL4K EUDAMED
- EMDN Code
- H020201010101,H020301040199 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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 Stapler Reload Unit by Wuxi Beien Surgery Device Co., Ltd. — Class IIb — 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 | 69717687MANUAL4K | Class IIb | Active |
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Manufacturer
- Manufacturer
- Wuxi Beien Surgery Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000017684
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 54b6d8b4-45e4-4fa3-bba2-04f9ef6b23d4 61 fields · synced May 23, 2026