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Aptima® APTIMA SWAB SPECIMEN COLLECTION KIT

by Hologic

Part of a family of 11 devices: see the family page

Ref 301041

Aptima® APTIMA SWAB SPECIMEN COLLECTION KIT (301041) is a device classified as Class A in the EU and Class II in the US made by Hologic, registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 54200455DIAGCOLLECTVT) and listed in FDA GUDID since 15 Apr 2016 (UDI-DI 25420045506272), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number54200455DIAGCOLLECTVT Basic UDI-DI 25420045506272UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number25420045506272 UDI-DI Date15 Apr 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 54200455DIAGCOLLECTVT registered 23 Jun 2026 Active
  • FDA GUDID UDI-DI 25420045506272 listed 15 Apr 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 25420045506272
  2. Registered EUDAMED 54200455DIAGCOLLECTVT

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  • Withdrawn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
Aptima Unisex Swab Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens EUDAMED
Aptima® GUDID
Generic name
Urogenital specimen collection kit IVD, clinical
Device name
Collection, Transport and Lysis Kits
Model / Ref / Catalog
301041, APTIMA SWAB SPECIMEN COLLECTION KIT
Primary DI / UDI-DI
25420045506272
Basic UDI-DI
54200455DIAGCOLLECTVT
Unit of use DI
15420045506275
FDA product code
NSU, MKZ, LSL
EMDN code
W05019099 Samples collection devices - other
GMDN term
Urogenital specimen collection kit IVD, clinical
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.2570, 866.3120, 866.3390
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
301041
GUDID
APTIMA SWAB SPECIMEN COLLECTION KIT
Device classEUDAMED
Class A
GUDID
Class II

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

Related devices

Category: Faecal parasite specimen concentration kit IVDUrogenital specimen collection kit IVD, clinical

Similar devices in this category

Other devices filed under SAMPLES COLLECTION DEVICES - OTHER.

Other devices from Hologic

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Properties

  • IVD kit
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)