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ThinPrep® Non-GYN Filters, 100pk

by Hologic

Ref 70205-001

ThinPrep® Non-GYN Filters, 100pk (70205-001) 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 54200455CYTFILTERS2L) and listed in FDA GUDID since 10 Sep 2018 (UDI-DI 25420045509662), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number54200455CYTFILTERS2L Basic UDI-DI 25420045509662UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number25420045509662 UDI-DI Date10 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 54200455CYTFILTERS2L registered 3 Sep 2026 Active
  • FDA GUDID UDI-DI 25420045509662 listed 10 Sep 2018 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 25420045509662
  2. Registered EUDAMED 54200455CYTFILTERS2L

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  • Withdrawn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 Non-Gynecological Filters EUDAMED
ThinPrep GUDID
Generic name
Microscope slide maker IVD
Device name
ThinPrep Filters
Model / Ref / Catalog
70205-001, ThinPrep® Non-GYN Filters, 100pk
Primary DI / UDI-DI
25420045509662
Basic UDI-DI
54200455CYTFILTERS2L
Unit of use DI
15420045509665
FDA product code
KET
EMDN code
W02029099 Various hematology / histology / cytology instruments - other
GMDN term
Microscope slide maker 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
70205-001
GUDID
ThinPrep® Non-GYN Filters, 100pk
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: Microscope slide maker IVD

Similar devices in this category

Other devices filed under VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER.

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Properties

  • Single use
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)