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Wesley
EUDAMEDClass IIb (EU MDR)
Ref 009Model W-T2008-B,C919,W139Ref 003Model W-T6008S,W139A,C939Ref 008
Identity
- Trade Name
- Wesley EUDAMED
- Device Name
- Haemodialysis Machine EUDAMED
- Model / Reference
- W-T2008-B,C919,W139 EUDAMED009 EUDAMEDW-T6008S,W139A,C939 EUDAMED003 EUDAMED008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974984380097 EUDAMED06974984380035 EUDAMED06974984380080 EUDAMED
- Basic UDI-DI
- 697498438WSL0014E EUDAMED697498438WSL0024G EUDAMED
- Direct Marketing DI
- 06974984380097 EUDAMED06974984380035 EUDAMED06974984380080 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 (3)
- EUDAMED 297f908b-dfd7-4771-b79c-fb639c3fa5b2 61 fields · synced Aug 3, 2026
- EUDAMED 0999d3e1-6f17-4c54-8f8b-1d9d7a36db8b 61 fields · synced May 17, 2026
- EUDAMED 0338ac74-eff4-47d7-94ae-71bb31dc584c 61 fields · synced May 18, 2026