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ZyMōt® Multi Sperm Separation Device
EUDAMEDClass IIa (EU MDR)
Ref ZMH3000MModel ZMH0850M
Identity
- Trade Name
- ZyMōt® Multi Sperm Separation Device EUDAMED
- Device Name
- ZyMōt Multi Sperm Separation Device EUDAMED
- Model / Reference
- ZMH0850M EUDAMEDZMH3000M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00888937027952 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
- Austria 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 c8e49e49-4951-4816-8d87-4617cc1eba5d 61 fields · synced Jul 11, 2026