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Dialyzer Reprocessing Machine
EUDAMEDClass IIb (EU MDR)
Ref FYYYMMModel W-F168-A,W-F168-B
Identity
- Trade Name
- Dialyzer Reprocessing Machine EUDAMED
- Device Name
- Dialyzer Reprocessing Machine EUDAMED
- Model / Reference
- W-F168-A,W-F168-B EUDAMEDFYYYMM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974984380011 EUDAMED
- Basic UDI-DI
- B-06974984380011 EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical utensil washer/disinfector
Dialyzer Reprocessing Machine by Chengdu Wesley Bioscience Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974984380011 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Chengdu Wesley Bioscience Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024552
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED aad7bc68-06b8-489a-8b85-160739985477 61 fields · synced Jul 14, 2026