Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator EUDAMEDKiwi® OmniCup® FDA UDI
- Generic Name
- Foetal vacuum extraction system cup, single-use FDA UDI
- Device Name
- Kiwi Complete Vacuum Delivery System EUDAMEDKiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator FDA UDI
- Model / Reference
- VAC-6000ME EUDAMEDVAC-6000MTE EUDAMEDFDA UDI
- Description
- Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020659 EUDAMEDFDA UDI
- Basic UDI-DI
- 0814247006000RP EUDAMED
- 510(k) Number
- K981260 FDA UDI
- FDA Product Code
- HDB FDA UDI
- EMDN Code
- Z12080301 OBSTETRIC VACUUM EXTRACTORS EUDAMED
- GMDN Term
- Foetal vacuum extraction system cup, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4340 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Foetal vacuum extraction system cup, single-use
Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator by Clinical Innovations, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0814247006000RP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
- EUDAMED SRN
- US-MF-000031386
- Authorised Representative
- MVF FR-AR-000011189
Sources (2)
- EUDAMED e79b4a00-5aaa-443f-a4a2-29c7b7e6a8fe 61 fields · synced Jul 12, 2026
- FDA UDI dc9d1ab4-6525-4f4c-b41c-96996e4b1bc3 34 fields · synced May 30, 2026