Solutran®hemo BioNest EF System
by Meditalia Industriale Srl Italy EUDAMED
Ref 4310202000
EMDN B0105
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 00054-A | Date9 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 00054-A Issued
Quality management system EU MDR
- Notified body
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 9 Jul 2026
- Expires
- 30 May 2029
Specification
- Model / Reference
- 4310202000
- Primary DI / UDI-DI
- 08058480560066
- Basic UDI-DI
- 805848056EFVW
- EMDN Code
- B0105 Umbilical cord blood collection, purification, cryopreservation bags and kits
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000032344
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 79bd2783-ae4a-4f94-a5f7-2bda97e66617