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KT ™ Premium Slides

by Slmp, LLC 47 variants

Ref KT1-GR-90

KT ™ Premium Slides (KT1-GR-90) is a device classified as Class A in the EU and Class I in the US made by Slmp, LLC, registered in EUDAMED on 6 Sep 2023 (Basic UDI-DI 4062418microscopeslidesV2) and listed in FDA GUDID since 19 Dec 2024 (UDI-DI 04062418015362), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04062418015362 UDI-DI Date19 Dec 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number4062418microscopeslidesV2 Basic UDI-DI 04062418015362UDI-DIDate6 Sep 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4062418microscopeslidesV2 registered 6 Sep 2023 Active
  • FDA GUDID UDI-DI 04062418015362 listed 19 Dec 2024 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Registered EUDAMED 4062418microscopeslidesV2
  2. Listed FDA GUDID 04062418015362

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
KT Premium Non-Adhesion Microscope Slides EUDAMED
KT ™ Premium Slides GUDID
Generic name
General specimen microscopy slide IVD, single-use
Device name
Microscope slides
Model / Ref / Catalog
KT1-GR-90, KT Slides KT1 uncoated premium slide, German glass, 90 degree corners, green, 14
Primary DI / UDI-DI
04062418015362
Basic UDI-DI
4062418microscopeslidesV2
FDA product code
KEW
EMDN code
W0503900201 Microscope slides
GMDN term
General specimen microscopy slide IVD, single-use
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.3010
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
KT1-GR-90
GUDID
KT Slides KT1 uncoated premium slide, German glass, 90 degree corners, green, 14
Device classEUDAMED
Class A
GUDID
Class I

Related devices

Category: General specimen microscopy slide IVD, single-use

Other devices from Slmp, LLC

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Properties

  • Single use
  • Professional testing
  • Premarket exempt
Other properties (23, all answered No)