Identity
- Trade Name
- welsuc EUDAMED
- Device Name
- Mini Negative Pressure Wound Therapy Device EUDAMED
- Model / Reference
- RH-S01 EUDAMED43020200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977508982005 EUDAMED
- Basic UDI-DI
- 697750898RHS01W7 EUDAMED
- Direct Marketing DI
- 06977508982005 EUDAMED
- EMDN Code
- A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa 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 Shenzhen Rainhome Medical Technology 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 | 697750898RHS01W7 | Class IIa | 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 d387c3de-b17e-4224-a1c0-85577679c8ba 61 fields · synced Oct 6, 2026