GK745
by Applied Medical Europe B.V. Netherlands EUDAMED
Ref GK745Model AME STANDARD KIT
EMDN K010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0607915PPIIA00084F | Date21 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ame Standard Kit
- Model / Reference
- AME STANDARD KIT, GK745
- Primary DI / UDI-DI
- 20607915140087
- Basic UDI-DI
- 0607915PPIIA00084F
- EMDN Code
- K010102 Minimally invasive surgery kits, single-use
- Device Class
- Class IIa
- Medical Purpose
- To enable hand and instrument access to the abdominal cavity.
Manufacturer details
- EUDAMED SRN
- NL-PR-000024031
Other devices from Applied Medical Europe
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- EUDAMED 20607915140087|0607915PPIIA00084F