Disposable Linear Cutter Staplers
by Wuxi Beien Surgery Device Co., Ltd. 27 variants
Ref 80ZFModel SQ80G
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06971767872718 06971767872718 | Date8 Apr 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- SQ80G, 80ZF
- Primary DI / UDI-DI
- 06971767872718
- Basic UDI-DI
- B-06971767872718
- EMDN Code
- H020201010102 Single patient straight linear staplers without blade for open surgery
- Device Class
- Class IIb
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000017684
- Authorised representative
- Prolinx GmbH DE-AR-000005129
Other devices from Wuxi Beien Surgery Device Co., Ltd.
Properties
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No