GK750
by Applied Medical Europe B.V. EUDAMED
Active
Ref GK750Model AME STANDARD KIT
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0607915PPIIA000447 | Date23 Jun 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- Withdrawn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, GK750
- Primary DI / UDI-DI
- 20607915140759
- Basic UDI-DI
- 0607915PPIIA000447
- EMDN Code
- K010102 Minimally invasive surgery kits, single-use
- Device Class
- Class IIa
- Medical Purpose
- To gain access for minimally invasive surgical procedures and to deliver sterile irrigation fluids and to evacuate blood, tissue debris and smoke from the surgical site.
Manufacturer details
- EUDAMED SRN
- NL-PR-000024031