Leukocyte Reduction Filter for Blood
by Nanjing Shuangwei Biotechnology Co., Ltd. China EUDAMED
Ref FTS-RC200, FTS-PL210, FTS-RC102, FTS-RC101, FTS-RC100, FTS-RC201, FTS-RC301 EMDN B02010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69523203FTSZQ | Date19 Jan 2026 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Device Name
- Leukocyte Reduction Filter for Blood
- Model / Reference
- FTS-RC200, FTS-PL210, FTS-RC102, FTS-RC101, FTS-RC100, FTS-RC201, FTS-RC301
- Primary DI / UDI-DI
- 06952320390306, 06952320391006, 06952320390207, 06952320390108, 06952320390009, 06952320390405, 06952320390702
- Basic UDI-DI
- 69523203FTSZQ
- EMDN Code
- B02010201, B02010202, B02010101
- Device Class
- Class IIb
Manufacturer details
- EUDAMED SRN
- CN-MF-000023311
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (7)
- EUDAMED dcaae33f-83eb-4a8e-a2a6-b184ec788700
- EUDAMED 06952320391006|69523203FTSZQ
- EUDAMED 06952320390207|69523203FTSZQ
- EUDAMED 06952320390108|69523203FTSZQ
- EUDAMED 06952320390009|69523203FTSZQ
- EUDAMED 06952320390405|69523203FTSZQ
- EUDAMED 06952320390702|69523203FTSZQ