← Back to catalogue
Waterproof Breathable Wound Dressing
EUDAMEDClass I (EU MDR)
Ref WB-01
by Well Shine
Identity
- Trade Name
- Waterproof Breathable Wound Dressing EUDAMED
- Device Name
- Waterproof Breathable Wound Dressing EUDAMED
- Model / Reference
- WB-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719893470017 EUDAMED
- Basic UDI-DI
- 471989347WellshineWBHT EUDAMED
- EMDN Code
- M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Waterproof Breathable Wound Dressing by Well Shine — Class I — 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 | 471989347WellshineWBHT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Well Shine
- EUDAMED SRN
- TW-MF-000050328
- Authorised Representative
- Surpass Biomedical Europe B.V. NL-AR-000038619
Sources (1)
- EUDAMED 8c06be85-55c7-47e4-8ffc-210cd3e7cc32 61 fields · synced Jul 14, 2026