INTERCEPT Processing Set for Small Volume (SV) Platelet Units
Ref INT21, INT2103B
Active
CE MDR
Valid until
2 Mar 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number872058919007PLT2L 18717953197020 | Date6 Oct 2025 | StatusActive |
Certificates
- G70 104609 0007 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 31 Jul 2025
- Expires
- 2 Mar 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- INTERCEPT Processing Set for Platelets
- Model / Reference
- INT21, INT2103B
- Primary DI / UDI-DI
- 18717953197020
- Basic UDI-DI
- 872058919007PLT2L
- EMDN Code
- B010199 Blood collection bags and kits - other
- Device Class
- Class III
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- US-MF-000000765
- Authorised representative
- Cerus Europe B.V. NL-AR-000000115
Other devices from Cerus Corporation
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No