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Dermlite

by DermLite LLC 9 variants

Ref DL4Model 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 Number085599700630276 Basic UDI-DI 08559970063024UDI-DIDate8 Jul 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  • Withdrawn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
DL4
Device Name
DermLite DL4
DermLite Devices including DL5P and Skeen SK2
Model / Reference
DL4, DermLite Devices including DL5P and Skeen SK2
Primary DI / UDI-DI
08559970063024
Basic UDI-DI
085599700630276, 0855997006DL180218J
Direct Marketing DI
08559970063024
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