Single Use Powered Endoscopic Linear Cutter Stapler
by Surgaid Medical(Xiamen) Co., Ltd. EUDAMED
Active
Ref PRU-E×60Model PRU-E×45
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69267420ST01008K4 | Date17 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Model / Reference
- PRU-E×45, PRU-E×60
- Primary DI / UDI-DI
- 06926742063353
- Basic UDI-DI
- 69267420ST01008K4
- EMDN Code
- H020301040102 Single patient straight linear staplers with blade for laparoscopy
- Device Class
- Class IIa
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000022724
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Surgaid Medical(Xiamen) 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