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Hollow fiber hemodialyzer low-flux HD-10L
EUDAMEDClass IIb (EU MDR)
Ref HD-10L-001Model HD-10L，HD-12L，HD-13L，HD-14L，HD-15L，HD-16L，HD-17L，HD-18L，HD-19L，HD-20L
Identity
- Trade Name
- Hollow fiber hemodialyzer low-flux HD-10L EUDAMED
- Device Name
- Hollow fiber hemodialyzer low-flux EUDAMED
- Model / Reference
- HD-10L，HD-12L，HD-13L，HD-14L，HD-15L，HD-16L，HD-17L，HD-18L，HD-19L，HD-20L EUDAMEDHD-10L-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 66920756718508 EUDAMED
- Basic UDI-DI
- 69207567KXXWTXQ00028Y EUDAMED
- EMDN Code
- F01060103 DIALYSERS - UFC < 18 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hollow fiber hemodialyzer low-flux HD-10L 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 | 69207567KXXWTXQ00028Y | 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 b1181a68-3246-4983-8b3f-418fd568daf4 61 fields · synced Jun 19, 2026