AC Medical Freezer
by Auguste Cryogenics Slovakia s.r.o. Slovakia EUDAMED
Ref AC BIO 430X, AC SYS 480, AC BIO 430, AC BIO 860, AC IVF 430Model AC Medical Freezer EMDN Z121702
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8588009681ACFSDC | Date24 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2026-MDR/QS-012 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 9 Feb 2026
- Expires
- 9 Feb 2031
Specification
- Device Name
- Medical Freezer
- Model / Reference
- AC Medical Freezer, AC BIO 430X, AC SYS 480, AC BIO 430, AC BIO 860, AC IVF 430
- Primary DI / UDI-DI
- 08588009681045, 08588009681038, 08588009681007, 08588009681021, 08588009681014
- Basic UDI-DI
- 8588009681ACFSDC
- Direct Marketing DI
- 0858800968104508588009681038085880096810070858800968102108588009681014
- EMDN Code
- Z121702 Blood and blood components freezers
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- SK-MF-000026173
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (5)
- EUDAMED 89d32348-281d-4193-a413-d1669fffba86
- EUDAMED 08588009681038|8588009681ACFSDC
- EUDAMED 08588009681007|8588009681ACFSDC
- EUDAMED 08588009681021|8588009681ACFSDC
- EUDAMED 08588009681014|8588009681ACFSDC