INTERCEPT Processing Set for Plasma
by Cerus Corporation 2 variants
Ref INT3103Model INT31
Active
CE MDR
Valid until
23 Aug 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number872058919008PLS2R 18717953197105 | Date7 Mar 2025 | StatusActive |
Certificates
- G70 104609 0008 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 24 Aug 2023
- Expires
- 23 Aug 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
EU market availability
Made available in 31 countries, as listed in EUDAMED:
- Austria since 20 Oct 2006
- Belgium since 20 Oct 2006
- Bulgaria since 20 Oct 2006
- Croatia since 20 Oct 2006
- Cyprus since 20 Oct 2006
- Czechia since 20 Oct 2006
- Denmark since 20 Oct 2006
- Estonia since 20 Oct 2006
- Finland since 20 Oct 2006
- France since 20 Oct 2006
- Germany since 20 Oct 2006
- Greece since 20 Oct 2006
- Hungary since 20 Oct 2006
- Iceland since 20 Oct 2006
- Ireland since 20 Oct 2006
- Italy since 20 Oct 2006
- Latvia since 20 Oct 2006
- Liechtenstein since 20 Oct 2006
- Lithuania since 20 Oct 2006
- Luxembourg since 20 Oct 2006
- Malta since 20 Oct 2006
- Netherlands since 20 Oct 2006
- Norway since 20 Oct 2006
- Poland since 20 Oct 2006
- Portugal since 20 Oct 2006
- Romania since 20 Oct 2006
- Slovakia since 20 Oct 2006
- Slovenia since 20 Oct 2006
- Spain since 20 Oct 2006
- Sweden since 20 Oct 2006
- Türkiye since 20 Oct 2006
Specification
- Model / Reference
- INT31, INT3103
- Primary DI / UDI-DI
- 18717953197105
- Basic UDI-DI
- 872058919008PLS2R
- 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