Identity
- Trade Name
- CryotopSC(Y) FDA UDI
- Generic Name
- Assisted reproduction vitrification carrier FDA UDI
- Device Name
- Cryotop® EUDAMED
- Model / Reference
- 81125 EUDAMEDCryotopSC(Y) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582231461943 EUDAMEDFDA UDI
- Basic UDI-DI
- 458223146CRYJS EUDAMED
- FDA Product Code
- MQK FDA UDI
- EMDN Code
- U08020401 CRYOPRESERVATION CONTAINERS/STRAWS/VIALS FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- Assisted reproduction vitrification carrier FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6160 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Cryotop® by Kitazato Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458223146CRYJS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Kitazato Corporation
- EUDAMED SRN
- JP-MF-000018374
- Authorised Representative
- BIOMEDICAL SUPPLY, S.L. ES-AR-000014358
Sources (2)
- EUDAMED 07e5f741-caee-42d8-b4b6-f0bbaf1f8980 61 fields · synced Jul 8, 2026
- FDA UDI 222c1a15-122b-4b57-8cff-af16ec45769c 33 fields · synced May 25, 2026