Kiwi® Vacuum Delivery System ProCup®
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Kiwi® Vacuum Delivery System ProCup® EUDAMEDKiwi® ProCup® FDA UDI
- Generic Name
- Foetal vacuum extraction system cup, single-use FDA UDI
- Device Name
- Kiwi Complete Vacuum Delivery System EUDAMEDKiwi® Vacuum Delivery System ProCup® FDA UDI
- Model / Reference
- VAC-6000ME EUDAMEDVAC-6000S EUDAMEDFDA UDI
- Description
- Kiwi® Vacuum Delivery System ProCup® FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020666 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 ProCup® by Clinical Innovations, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Foetal vacuum extraction system cup, single-use.
- MityOne® Pump with M-Style® — CooperSurgical, Inc. · Class IIa
- CMI — Utah Medical Products, Inc. · Class II
- Mityvac® MitySoft® — CooperSurgical, Inc. · Class IIa
- ATMOS S 351 NATAL mobile, 230 V — ATMOS MedizinTechnik GmbH & Co. KG · Class IIa
- ATMOS S 351 NATAL – basic set, 230 V (Medi-Vac®) — ATMOS MedizinTechnik GmbH & Co. KG · Class IIa
- ATMOS S 351 NATAL, 230 V — ATMOS MedizinTechnik GmbH & Co. KG · Class IIa
- Mityvac® — CooperSurgical, Inc. · Class IIa
- Silicone Birth Vac Cup — FORTUNE MEDICAL INSTRUMENT CORP. · Class IIa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clinical Innovations, LLC
- EUDAMED SRN
- US-MF-000031386
- Authorised Representative
- MVF FR-AR-000011189
Sources (2)
- EUDAMED e37e4c30-6bd9-4178-af5e-05ade6ee1e2f 61 fields · synced Jul 30, 2026
- FDA UDI 3dbe83da-cba5-42b9-8c3b-3d37c59c7b34 34 fields · synced May 30, 2026