Identity
- Trade Name
- Wesley EUDAMED
- Device Name
- Haemodialysis Machine EUDAMED
- Model / Reference
- W-T2008-B,C919,W139 EUDAMED007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974984380073 EUDAMED
- Basic UDI-DI
- 697498438WSL0014E EUDAMED
- Direct Marketing DI
- 06974984380073 EUDAMED
- EMDN Code
- F9099 DIALYSIS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
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
Wesley by Chengdu Wesley Bioscience Technology 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 | 697498438WSL0014E | 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 96e6f46d-79a5-4088-87ad-d969842fd3df 61 fields · synced Jun 18, 2026