Identity
- Trade Name
- welsuc EUDAMED
- Device Name
- Single Use Negative Pressure Wound Therapy Dressing EUDAMED
- Model / Reference
- A-1 EUDAMED43010205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977508983033 EUDAMED
- Basic UDI-DI
- 697750898PICOWN EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
Yes
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
welsuc by Shenzhen Rainhome Medical 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 | 697750898PICOWN | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Rainhome Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000054135
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 5a4fdf91-c613-4d07-9a73-7befc24dc2d0 61 fields · synced Oct 6, 2026