Identity
- Device Name
- Cryotop® EUDAMED
- Model / Reference
- 81115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582231460922 EUDAMED
- Basic UDI-DI
- 458223146CRYJS EUDAMED
- EMDN Code
- U08020401 CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Cryotop® by Kitazato Corporation — 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 | 458223146CRYJS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kitazato Corporation
- EUDAMED SRN
- JP-MF-000018374
- Authorised Representative
- BIOMEDICAL SUPPLY, S.L. ES-AR-000014358
Sources (1)
- EUDAMED 6aa18131-1814-4e52-bfa7-c4f046f432e7 61 fields · synced May 23, 2026