Solutran®hemo BioNest ABC D
by Meditalia Industriale Srl Italy EUDAMED
Ref 4911002200 EMDN B019001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 00054-A | Date9 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Device Name
- Solutran®hemo BioNest System for UCB
- Model / Reference
- 4911002200
- Primary DI / UDI-DI
- 08058480560004
- Basic UDI-DI
- 805848056CordSH
- EMDN Code
- B019001 Platelet gel and fibrin glue production bags and kits
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000032344
Other devices from Meditalia Industriale Srl
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 1181b42f-4dd9-4a99-9ae5-07cc506c7682