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Hollow Fiber Haemodiafilter
EUDAMEDClass IIb (EU MDR)
Ref SC021Model HDF15, HDF16, HDF17, HDF18, HDF19, HDF20, HDF21, HDF22, HDF23
Identity
- Trade Name
- Hollow Fiber Haemodiafilter EUDAMED
- Device Name
- Hollow Fiber Haemodiafilter EUDAMED
- Model / Reference
- HDF15, HDF16, HDF17, HDF18, HDF19, HDF20, HDF21, HDF22, HDF23 EUDAMEDSC021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 56947793303767 EUDAMED
- Basic UDI-DI
- 69477933HaemodiafilterN3 EUDAMED
- Unit of Use DI
- 06947793303762 EUDAMED
- EMDN Code
- F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 Haemodiafilter by Shandong Weigao Blood Purification Products Co., 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 | 69477933HaemodiafilterN3 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000012203
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED 96acb5e6-253f-4414-84ae-8d57aefe3df3 61 fields · synced Oct 6, 2026