Disposable Hemoperfusion Cartridge
by Jafron Biomedical Co., Ltd. China EUDAMED
Ref HA200Model HA60 HA80 HA100 HA130 HA150 HA180 HA200 HA230 HA250 HA280 HA300 HA350 HA330-Ⅱ HA380 HA430 HA480
EMDN F010702
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-06938450812000 | Date27 Oct 2023 | StatusActive |
| European Union | CE/MDD | NumberB-06938450812000 | Date27 Oct 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Model / Reference
- HA200, HA60 HA80 HA100 HA130 HA150 HA180 HA200 HA230 HA250 HA280 HA300 HA350 HA330-Ⅱ HA380 HA430 HA480
- Primary DI / UDI-DI
- 06938450812000, 06938450816138
- Basic UDI-DI
- B-06938450812000, 69384508HAGB
- EMDN Code
- F010702 Haemoperfusion resin filters
- Device Class
- Class IIb
- Market of Registration
- AustriaGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000018067
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Jafron Biomedical 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 (2)
- EUDAMED 045abd3a-e418-4c58-bf99-b09815f3854b
- EUDAMED 06938450816138|69384508HAGB