Identity
- Device Name
- ZyMōt Multi Sperm Separation Device EUDAMED
- Model / Reference
- ZMH0850M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00888937027945 EUDAMED
- Basic UDI-DI
- 0888937TD141ZN EUDAMED
- EMDN Code
- U080207 CONTAINERS FOR PREPARATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
ZyMōt Multi Sperm Separation Device by CooperSurgical, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0888937TD141ZN | Class IIa | Active |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
- EUDAMED SRN
- US-MF-000002607
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (1)
- EUDAMED 38d5cdc5-ea99-4875-88c7-1604d5b16afd 61 fields · synced Jul 19, 2026