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ThinPrep Imaging System

by Hologic

Ref ASY-07317

ThinPrep Imaging System (ASY-07317) is a device classified as Class A in the EU and Class III in the US made by Hologic, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 54200455CYTSLIDESGZ), approved under FDA PMA P950039 on 20 May 1996 and listed in FDA GUDID since 11 Sep 2014 (UDI-DI 25420045501093), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

PMA P950039

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number54200455CYTSLIDESGZ Basic UDI-DI 25420045501093UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number25420045501093 UDI-DI Date11 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP950039 Date20 May 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 54200455CYTSLIDESGZ registered 3 Sep 2026 Active
  • FDA PMA P950039 decided 20 May 1996 Active
  • FDA GUDID UDI-DI 25420045501093 listed 11 Sep 2014 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Approved FDA PMA P950039
  2. Listed FDA GUDID 25420045501093
  3. Registered EUDAMED 54200455CYTSLIDESGZ

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ThinPrep Imaging System Microscope Slides EUDAMED
ThinPrep Imaging System GUDID
Generic name
Cervical cytology microscopy slide IVD
Device name
ThinPrep Microscope Slides
Model / Ref / Catalog
ASY-07317, ThinPrep® Imaging System Microscope Slides, 100pk
Primary DI / UDI-DI
25420045501093
Basic UDI-DI
54200455CYTSLIDESGZ
Unit of use DI
15420045501096
PMA number
FDA product code
MKQ
EMDN code
W0503900201 Microscope slides
GMDN term
Cervical cytology microscopy slide IVD
Device class
Class A EUDAMED
Class III GUDID
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
ASY-07317
GUDID
ThinPrep® Imaging System Microscope Slides, 100pk
Device classEUDAMED
Class A
GUDID
Class III

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class III 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

Cleared under the same submission (P950039)

and 8 more cleared under P950039

Similar devices in this category

Other devices filed under MICROSCOPE SLIDES.

Other devices from Hologic

See all devices from Hologic →

Properties

  • Single use
  • Professional testing
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)