Identity
- Trade Name
- Wesley EUDAMED
- Device Name
- Haemodialysis Machine EUDAMED
- Model / Reference
- W-T6008S,W139A,C939 EUDAMED010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974984380103 EUDAMED
- Basic UDI-DI
- 697498438WSL0024G EUDAMED
- Direct Marketing DI
- 06974984380103 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 | 697498438WSL0024G | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chengdu Wesley Bioscience Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024552
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED a59bca1a-6134-4561-b133-2ccdaa26593e 61 fields · synced Jun 19, 2026