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Skeen

by DermLite LLC EUDAMEDGUDID

Active European Union

Ref SK2Model DermLite Devices including DL5P and Skeen SK2

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08500176518382 UDI-DIDate28 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number850017651838B6 Basic UDI-DIDate25 Sep 2026RegisteredStatusActive

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  • Withdrawn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
Skeen EUDAMED
DermLite Skeen SK2 EUDAMED
DermLite Skeen GUDID
Generic Name
Dermatoscope, optical
Device Name
DermLite Devices including DL5P and Skeen SK2
Model / Ref / Catalog
SK2, DermLite Devices including DL5P and Skeen SK2
Primary DI / UDI-DI
08500176518382
Basic UDI-DI
850017651838B6, 0855997006DL180218J
Direct Marketing DI
08500176518382
FDA Product Code
KYT
EMDN Code
Z12040108 Dermatoscopes
GMDN Term
Dermatoscope, optical
Device Class
Class I
Regulation Number
880.6350
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

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