Skip to content

Dermlite

by DermLite LLC 9 variants

Ref GLBModel DermLite Devices including DL5P and Skeen SK2

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850017651104S7 Basic UDI-DI 08500176511048UDI-DIDate28 Jun 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Dermlite
Glb
Device Name
DermLite GL Battery
DermLite Devices including DL5P and Skeen SK2
Model / Reference
GLB, DermLite Devices including DL5P and Skeen SK2
Primary DI / UDI-DI
08500176511048
Basic UDI-DI
0850017651104S7, 0855997006DL180218J
Direct Marketing DI
08500176511048
EMDN Code
Z12040108 Dermatoscopes
Device Class
Class I
Market of Registration
Germany
Italy

Manufacturer details

EUDAMED SRN
US-MF-000005170
Authorised representative
E C REP LIMITED IE-AR-000003995

Other devices from DermLite LLC

See all devices from DermLite LLC →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No