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Disposable Linear Cutter Staplers
EUDAMEDClass IIb (EU MDR)
Ref 8038DModel BLC80
Identity
- Trade Name
- Disposable Linear Cutter Staplers EUDAMED
- Device Name
- Disposable Linear Cutter Staplers EUDAMED
- Model / Reference
- BLC80 EUDAMED8038D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767878017 EUDAMED
- Basic UDI-DI
- B-06971767878017 EUDAMED
- EMDN Code
- H020201010102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland 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
Disposable Linear Cutter Staplers by Wuxi Beien Surgery Device Co., Ltd. — Class IIb — 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-06971767878017 | 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 00c4967a-d9a3-4edb-9f2a-c88bd28dd9df 61 fields · synced May 23, 2026