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Hollow Fiber Hemodialyzer high-flux
EUDAMEDClass IIb (EU MDR)
Ref HD-16H-001 Model HD-10H、HD-12H、HD-13H、HD-14H、HD-15H、HD-16H、HD-17H、HD-18H、HD-19H、HD-20H
Identity
- Trade Name
- Hollow Fiber Hemodialyzer high-flux EUDAMED
- Device Name
- Hollow Fiber Hemodialyzer EUDAMED
- Model / Reference
- HD-10H、HD-12H、HD-13H、HD-14H、HD-15H、HD-16H、HD-17H、HD-18H、HD-19H、HD-20H EUDAMEDHD-16H-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 66920756718058 EUDAMED
- Basic UDI-DI
- 69207567KXXWTXQ00018W EUDAMED
- EMDN Code
- F01060203 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hollow Fiber Hemodialyzer high-flux by Jiangxi Hongda Medical Equipment Group Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69207567KXXWTXQ00018W | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jiangxi Hongda Medical Equipment Group Ltd.
- EUDAMED SRN
- CN-MF-000006019
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 101ae6b6-482c-4cd9-a161-851502889952 61 fields · synced Jul 8, 2026