EUDAMED device
Kiwi® Vacuum Delivery System, OmniCup®
EUDAMED device 00814247020635 · Clinical Innovations, LLC
Key facts
| Primary DI | 00814247020635 |
|---|---|
| Trade name | Kiwi® Vacuum Delivery System, OmniCup® |
| Device name | Kiwi® OmniCup® |
| Reference or catalog number | VAC-6000 ME |
| Model | VAC-6000 ME |
| Manufacturer | Clinical Innovations, LLC |
| Manufacturer SRN | US-MF-000031386 |
| Risk class | Class IIa |
| EMDN code | Z12080301 |
| EMDN description | OBSTETRIC VACUUM EXTRACTORS |
| Legislation | mdd |
| Implantable | No |
| Sterile | Yes |
| Single use | Yes |
| Status date | Sep 19, 2025 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: