Ame Standard Kit
by Applied Medical Europe B.V. EUDAMED
Active
Ref CL103Model AME STANDARD KIT
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0607915PPIIB00044J | Date13 Jul 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- Withdrawn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, CL103
- Primary DI / UDI-DI
- 20607915149011
- Basic UDI-DI
- 0607915PPIIB00044J
- EMDN Code
- K010102 Minimally invasive surgery kits, single-use
- Device Class
- Class IIb
- Medical Purpose
- To enable single incision access in minimally invasive surgical procedures and to ligate and divide vessels, lymphatics and tissue bundles.
Manufacturer details
- EUDAMED SRN
- NL-PR-000024031