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Dermlite

by DermLite LLC EUDAMEDGUDID

Active European Union

Ref DL1SModel DermLite Devices including DL5P and Skeen SK2

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08559970069999D Basic UDI-DIDate26 Aug 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08559970069996 UDI-DIDate17 Jun 2024ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Dermlite EUDAMED
DL1S EUDAMED
DL1 Polarized Spacer GUDID
Generic Name
Dermatoscope, optical
Device Name
DermLite Devices including DL5P and Skeen SK2
Model / Ref / Catalog
DL1S, DermLite Devices including DL5P and Skeen SK2
Primary DI / UDI-DI
08559970069996 EUDAMED
00855997006999 GUDID
Basic UDI-DI
08559970069999D, 0855997006DL180218J
Direct Marketing DI
08559970069996
FDA Product Code
KYT
EMDN Code
Z12040108 Dermatoscopes
GMDN Term
Dermatoscope, optical
Device Class
Class I
Regulation Number
880.6350
Market of Registration
Germany
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08559970069996
GUDID
00855997006999

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

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No
  • Manufacturing Date: No