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ThinPrep® Arcless Microscope Slides

by Hologic

Ref 70126-002

ThinPrep® Arcless Microscope Slides (70126-002) is a device classified as Class A in the EU and Class I in the US made by Hologic, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 54200455CYTSLIDESGZ) and listed in FDA GUDID since 6 Feb 2019 (UDI-DI 25420045509990), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number54200455CYTSLIDESGZ Basic UDI-DI 25420045509990UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number25420045509990 UDI-DI Date6 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 54200455CYTSLIDESGZ registered 3 Sep 2026 Active
  • FDA GUDID UDI-DI 25420045509990 listed 6 Feb 2019 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. Listed FDA GUDID 25420045509990
  2. Registered EUDAMED 54200455CYTSLIDESGZ

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  • Withdrawn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
ThinPrep Arcless Microscope Slides EUDAMED
ThinPrep GUDID
Generic name
Cervical cytology microscopy slide IVD
Device name
ThinPrep Microscope Slides
Model / Ref / Catalog
70126-002, ThinPrep® Arcless Microscope Slides
Primary DI / UDI-DI
25420045509990
Basic UDI-DI
54200455CYTSLIDESGZ
Unit of use DI
15420045509993
FDA product code
KEW
EMDN code
W0503900201 Microscope slides
GMDN term
Cervical cytology microscopy slide IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.3010
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
70126-002
GUDID
ThinPrep® Arcless Microscope Slides
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cervical cytology microscopy slide IVD

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Other devices filed under MICROSCOPE SLIDES.

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Properties

  • Single use
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)