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Skinuvita Phototherapy System
EUDAMEDClass IIa (EU MDR)
Ref 426243976SKUV+DL500R0XW
Identity
- Trade Name
- Skinuvita Phototherapy System EUDAMED
- Device Name
- Skinuvita Phototherapy System EUDAMED
- Model / Reference
- 426243976SKUV+DL500R0XW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262439760085 EUDAMED
- Basic UDI-DI
- 426243976SKUV+DL500R0XW EUDAMED
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The medical device system consisting of the Dermalight® 500R-0, the Skinuvita Phototherapy Solution, and the Skinuvita Connector is intended for use in ultraviolet (UV) phototherapy for the treatment and management of photoresponsive dermatological diseases, such as psoriasis and eczema. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Red-light phototherapy unit, professional
Skinuvita Phototherapy System by Skinuvita GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 426243976SKUV+DL500R0XW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Skinuvita GmbH
- EUDAMED SRN
- DE-PR-000052648
Sources (1)
- EUDAMED f3cad43a-7883-46eb-a37d-3f94bf243a25 61 fields · synced Oct 6, 2026