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Hollow Fiber Dialyzer
EUDAMEDClass IIb (EU MDR)
Ref TCZ0116Model 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 EUDAMEDTCZ0116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 56947793303132 EUDAMED
- Basic UDI-DI
- 69477933Dialyzer019J EUDAMED
- Unit of Use DI
- 06947793303137 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 b8e9b1f1-f2c8-4f06-a2d4-93bb1f9f9ddf 61 fields · synced Jun 18, 2026