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BD SurePath™ PreCoat Slides 491248

by Becton, Dickinson and Company

Ref 491248

BD SurePath™ PreCoat Slides 491248 is a device classified as Class A in the EU and Class III in the US made by Becton, Dickinson and Company, registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI 038290MJZIOXBDJ7) and listed in FDA GUDID since 8 Sep 2017 (UDI-DI 30382904912483), active as of 26 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 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038290MJZIOXBDJ7 Basic UDI-DI 30382904912483UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30382904912483 UDI-DI Date8 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038290MJZIOXBDJ7 registered 20 Jul 2026 Active
  • FDA GUDID UDI-DI 30382904912483 listed 8 Sep 2017 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 30382904912483
  2. Registered EUDAMED 038290MJZIOXBDJ7

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  • Withdrawn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
SurePath EUDAMED
BD SurePath™ PreCoat Slides GUDID
Generic name
Cervical cytology microscopy slide IVD
Model / Ref / Catalog
491248
Primary DI / UDI-DI
30382904912483
Basic UDI-DI
038290MJZIOXBDJ7
Unit of use DI
00382904912482
FDA product code
MKQ, KEW
EMDN code
W0202050385 Laboratory instruments for microscopic investigations - consumables
GMDN term
Cervical cytology microscopy slide IVD
Device class
Class A EUDAMED
Class III 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 · 1 field differs

FieldEUDAMEDGUDID
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

Similar devices in this category

Other devices filed under LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS.

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Properties

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