Identity
- Trade Name
- CRYOLOCK EUDAMED
- Device Name
- CRYOLOCK EUDAMED
- Model / Reference
- CL-R-CT EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B056CLRCT EUDAMED
- Basic UDI-DI
- ++B056CRYOLOCKFAMILYDEVW8 EUDAMED
- Unit of Use DI
- 1 EUDAMED
- EMDN Code
- U08020401 CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Cryolock by Biotech 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 | K122982 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B056CRYOLOCKFAMILYDEVW8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biotech Inc
- EUDAMED SRN
- US-MF-000002378
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED 0bf9bc65-546e-4907-acc4-af4a6a8f4cdd 61 fields · synced Aug 2, 2026
- FDA 510(k) K122982 1 fields · synced May 18, 2026