Disposable Powered Endoscopic Stapler
by Wuxi Beien Surgery Device Co., Ltd. 7 variants
Ref P430Model ELSP-45E
Active
CE MDR
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/MDR | Number697176787P430NJ 06971767871759 | Date17 Apr 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Powered Endoscopic Staplers
- Model / Reference
- ELSP-45E, P430
- Primary DI / UDI-DI
- 06971767871759
- Basic UDI-DI
- 697176787P430NJ
- EMDN Code
- H020201010101, H020301040199
- Device Class
- Class IIa
- Market of Registration
- Türkiye
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 (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No