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Skinuvita Phototherapy System

EUDAMED

Class IIa (EU MDR)

Ref 426243976SKUV+DL500R0XW

by Skinuvita GmbH

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

Similar devices

Also classified as Red-light phototherapy unit, professional.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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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