Identity
- Trade Name
- welsuc EUDAMED
- Device Name
- Negative Pressure Wound Therapy Dressing Kit EUDAMED
- Model / Reference
- PU-III EUDAMED43010123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938294453223 EUDAMED
- Basic UDI-DI
- 69382944PU000UE EUDAMED
- EMDN Code
- A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 Guangzhou Rainhome Pharm & Tech 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 | 69382944PU000UE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangzhou Rainhome Pharm & Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000027876
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED ef2b68ce-596e-4f27-a2de-da33ca8700ad 61 fields · synced Jun 19, 2026