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Disposable Linear Cutter Stapler Reload Unit
EUDAMEDClass IIb (EU MDR)
Ref 6038EModel BCA60
Identity
- Trade Name
- Disposable Linear Cutter Stapler Reload Unit EUDAMED
- Device Name
- Disposable Linear Cutter Staplers EUDAMED
- Model / Reference
- BCA60 EUDAMED6038E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767876037 EUDAMED
- Basic UDI-DI
- B-06971767876037 EUDAMED
- EMDN Code
- H0202010301 SINGLE-PATIENT LINEAR SUTURE CARTDRIGES WITH 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 Stapler Reload Unit 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-06971767876037 | 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 cb057505-9af8-4214-8c81-a038bd9727dc 61 fields · synced May 23, 2026