Identity
- Trade Name
- welsuc EUDAMED
- Device Name
- Negative pressure wound therapy device EUDAMED
- Model / Reference
- RH-450 EUDAMED43020102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938294470770 EUDAMED
- Basic UDI-DI
- 69382944FYJ450V4 EUDAMED
- EMDN Code
- A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa 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
welsuc by Guangzhou Rainhome Pharm & Tech Co., Ltd — Class IIa — 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 | 69382944FYJ450V4 | Class IIa | 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 1bf46937-e9e6-4eee-80ec-445a5ae03b87 61 fields · synced Jun 19, 2026