Identity
- Trade Name
- Tender Touch Cup EUDAMEDCMI FDA UDI
- Generic Name
- Foetal vacuum extraction system cup, single-use FDA UDI
- Device Name
- CMI Vacuum Delivery Cups EUDAMEDOBSTETRICAL VACUUM DELIVERY KIT, 60mm Tender Touch Cup, Tube, Fluid Trap FDA UDI
- Model / Reference
- 404TT EUDAMEDTender Touch Cup FDA UDI
- Description
- OBSTETRICAL VACUUM DELIVERY KIT, 60mm Tender Touch Cup, Tube, Fluid Trap FDA UDI
Identifiers
- Catalog Number
- 404TT FDA UDI
- Primary DI / UDI-DI
- H671404TT0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++H671CE012IIAC4 EUDAMED
- 510(k) Number
- K910788 FDA UDI
- FDA Product Code
- HIS 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
- 884.5300 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 60 Millimeter FDA UDI
Category: Foetal vacuum extraction system cup, single-use
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, single-use.
- MityOne® Pump with M-Style® — CooperSurgical, Inc. · Class IIa
- 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
- Silicone Birth Vac Cup — FORTUNE MEDICAL INSTRUMENT CORP. · Class IIa
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (2)
- FDA UDI 98c16106-9685-470e-9d5a-5fe95a6e759d 37 fields · synced Jun 18, 2026
- EUDAMED 5b7136f8-2ec4-4963-ae88-c62a37fdfe2d 61 fields · synced Jun 18, 2026