Identity
- Trade Name
- Velvet Touch Cup EUDAMEDCMI FDA UDI
- Generic Name
- Foetal vacuum extraction system cup, reusable FDA UDI
- Device Name
- CMI Vacuum Delivery Cups EUDAMEDVELVET TOUCH, Vacuum Extractor Cup, Reusable Soft Silicone Cup for Vacuum Assisted Childbirth FDA UDI
- Model / Reference
- 202VT EUDAMEDVelvet Touch Cup FDA UDI
- Description
- VELVET TOUCH, Vacuum Extractor Cup, Reusable Soft Silicone Cup for Vacuum Assisted Childbirth FDA UDI
Identifiers
- Catalog Number
- 202VT FDA UDI
- Primary DI / UDI-DI
- 202VT EUDAMEDH671202VT0 FDA UDI
- Basic UDI-DI
- ++H671CE012IIAC4 EUDAMED
- 510(k) Number
- K942725 FDA UDI
- FDA Product Code
- HDB FDA UDI
- EMDN Code
- Z12080301 OBSTETRIC VACUUM EXTRACTORS EUDAMED
- GMDN Term
- Foetal vacuum extraction system cup, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4340 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 205 Millimeter FDA UDILumen/Inner Diameter — 65 Millimeter FDA UDI
Category: Foetal vacuum extraction system cup, reusable
Cmi by Utah Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Foetal vacuum extraction system cup, reusable.
- AESCULAP — AESCULAP, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (2)
- FDA UDI 5c391171-8f61-45ac-b7fc-5cf7395c58cd 37 fields · synced Oct 7, 2026
- EUDAMED 26a3cbb1-374e-4ea7-a89b-cbffd06164f9 61 fields · synced Jul 9, 2026