Identity
- Trade Name
- Cryotec EUDAMED
- Device Name
- Cryotec EUDAMED
- Model / Reference
- TEC 010Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04589700011036 EUDAMED
- Basic UDI-DI
- 458970001TECND EUDAMED
- EMDN Code
- U08020401 CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
Cryotec by Reprolife Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162051 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 458970001TECND | Class IIa | Active |
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Manufacturer
- Manufacturer
- REPROLIFE Inc.
- EUDAMED SRN
- JP-MF-000031415
- FDA Applicant
- Reprolife, Inc.
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED c6144f49-72f8-4a00-bf78-d9e11ee05876 85 fields · synced Jun 18, 2026
- FDA 510(k) K162051 1 fields · synced May 18, 2026