Hollow Fiber Hemodialyzer high-flux
by Jiangxi Hongda Medical Equipment Group Ltd. China EUDAMED
Ref HD-18H-001 Model HD-10H、HD-12H、HD-13H、HD-14H、HD-15H、HD-16H、HD-17H、HD-18H、HD-19H、HD-20H
EMDN F01060203
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69207567KXXWTXQ00018W | Date13 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Hollow Fiber Hemodialyzer
- Model / Reference
- HD-10H、HD-12H、HD-13H、HD-14H、HD-15H、HD-16H、HD-17H、HD-18H、HD-19H、HD-20H, HD-18H-001
- Primary DI / UDI-DI
- 66920756718072
- Basic UDI-DI
- 69207567KXXWTXQ00018W
- EMDN Code
- F01060203 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES
- Device Class
- Class IIb
- Market of Registration
- Hungary
Manufacturer details
- EUDAMED SRN
- CN-MF-000006019
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Jiangxi Hongda Medical Equipment Group Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 21ac5e8e-5118-4cad-8651-5695f21cc278