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Hollow Fiber Dialyzer
EUDAMEDClass IIb (EU MDR)
Ref TCD0115Model F10, F12, F13, F14, F15, F16, F17, F18, F19, F20, HF10, HF12, HF13, HF14, HF15, HF16, HF17, HF18, HF19, HF20, HF21, HF22, HF23, MF10, MF12, MF13, MF14, MF15, MF16, MF17, MF18, MF19, E15H, E16H, E17H, E18H, E19H, E20H, E21H, E22H, E23H
Identity
- Trade Name
- Hollow Fiber Dialyzer EUDAMED
- Device Name
- Hollow Fiber Dialyzer EUDAMED
- Model / Reference
- F10, F12, F13, F14, F15, F16, F17, F18, F19, F20, HF10, HF12, HF13, HF14, HF15, HF16, HF17, HF18, HF19, HF20, HF21, HF22, HF23, MF10, MF12, MF13, MF14, MF15, MF16, MF17, MF18, MF19, E15H, E16H, E17H, E18H, E19H, E20H, E21H, E22H, E23H EUDAMEDTCD0115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 56947793304290 EUDAMED
- Basic UDI-DI
- 69477933Dialyzer019J EUDAMED
- Unit of Use DI
- 06947793304295 EUDAMED
- EMDN Code
- F01060203 DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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 Dialyzer 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 | 69477933Dialyzer019J | 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 49123333-2524-4d9a-a74e-6853c0e8e54f 61 fields · synced Jun 19, 2026