Identity
- Trade Name
- CMI Sure Cup EUDAMED
- Device Name
- CMI Vacuum Delivery Cups EUDAMED
- Model / Reference
- 206SC EUDAMED
Identifiers
- Primary DI / UDI-DI
- H671206SC1 EUDAMED
- Basic UDI-DI
- ++H671CE012IIAC4 EUDAMED
- EMDN Code
- Z12080301 OBSTETRIC VACUUM EXTRACTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Foetal vacuum extraction system cup, single-use
CMI Sure Cup by Utah Medical Products, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++H671CE012IIAC4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
- EUDAMED SRN
- US-MF-000020583
- Authorised Representative
- Utah Medical Products Ltd IE-AR-000007796
Sources (1)
- EUDAMED 65819495-4aff-4985-8e65-710158d5ea23 61 fields · synced Jun 18, 2026