Identity
- Trade Name
- CBS™ Haute Sécurité EUDAMEDBATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - WHITE FDA UDI
- Generic Name
- Tissue cryostorage straw vitrification set FDA UDI
- Device Name
- Barquette de 4 paillettes de vitrification embryon CBS™ haute sécurité - blanc EUDAMED
- Model / Reference
- 025247 EUDAMED1 FDA UDI
Identifiers
- Catalog Number
- 025247 FDA UDI
- Primary DI / UDI-DI
- 03661532002978 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03661532002978 EUDAMED
- FDA Product Code
- MQK FDA UDI
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
- GMDN Term
- Tissue cryostorage straw vitrification set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6160 FDA UDI
- Market of Registration
- France 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assisted reproduction vitrification carrier
CBS™ Haute Sécurité by Cryo Bio System — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03661532002978 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cryo Bio System
- EUDAMED SRN
- FR-MF-000001630
Sources (2)
- EUDAMED 6e6c9972-8c26-4ed2-a6a3-3e6cb4ca965e 61 fields · synced Jul 16, 2026
- FDA UDI 846c89c3-5db1-4dd5-8e57-570b7513c947 33 fields · synced May 30, 2026