Solutran®hemo BioNest system for adult platelet donors
Ref 4911000900
Active
CE MDR
Valid until
30 May 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 00054-A | Date9 Jul 2026 | StatusActive |
Certificates
- MDR 00054-A Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 9 Jul 2026
- Expires
- 30 May 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 4911000900
- Primary DI / UDI-DI
- 08058480560073
- Basic UDI-DI
- 805848056ALIQH5
- EMDN Code
- B019003 Blood components aliquotation kits
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000032344
Other devices from Meditalia Industriale Srl
Properties
Other properties (12)
- 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