Disposable Plasma Apheresis Sets
by Haier Haematologi Chongqing Co., Ltd. China EUDAMED
Ref FLQ/B1G1C1D13Model FLQ/B1G1C1D13, FLQ/B1G1C1D3, FLQ/B1G1C1D15, FLQ/B1G1C1D14, FLQ/B1G1C1D1, FLQ/B1G1C1D12, FLQ/B1G1C1D11, FLQ/B1G1C1D2, FLQ/B1G1C1D21, FLQ/B1G1C1D22, FLQ/B1G1C1D23 EMDN B030101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697461485A001F6 | Date4 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Plasma Apheresis Set -bag
- Model / Reference
- FLQ/B1G1C1D13, FLQ/B1G1C1D3, FLQ/B1G1C1D15, FLQ/B1G1C1D14, FLQ/B1G1C1D1, FLQ/B1G1C1D12, FLQ/B1G1C1D11, FLQ/B1G1C1D2, FLQ/B1G1C1D21, FLQ/B1G1C1D22, FLQ/B1G1C1D23
- Primary DI / UDI-DI
- 06974614855025
- Basic UDI-DI
- 697461485A001F6
- EMDN Code
- B030101 Apheresis plasma collection devices
- Device Class
- Class IIb
- Market of Registration
- Iceland
Manufacturer details
- EUDAMED SRN
- CN-MF-000015706
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Haier Haematologi Chongqing Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 690602a8-8897-4d15-99f8-f1dd629342ec