GK1002
by Applied Medical Europe B.V. EUDAMED
Active
Ref GK1002Model AME STANDARD KIT
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0607915PPIIA000345 | Date1 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ame Standard Kit
- Model / Reference
- AME STANDARD KIT, GK1002
- Primary DI / UDI-DI
- 20607915144962
- Basic UDI-DI
- 0607915PPIIA000345
- EMDN Code
- V0599 Clinical procedures kits not included in other classes - other
- Device Class
- Class IIa
- Medical Purpose
- To enable open or laparoscopic surgery, providing atraumatic,circumferential retraction and protection.
Manufacturer details
- EUDAMED SRN
- NL-PR-000024031