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Beckman Coulter DxH Slides

by Beckman Coulter Inc.

Ref B01276

Beckman Coulter DxH Slides (B01276) is a device classified as Class A in the EU and Class I in the US made by Beckman Coulter, Inc., registered in EUDAMED on 28 Aug 2024 (Basic UDI-DI 150995901HEMACCESSORYP8) and listed in FDA GUDID since 11 Nov 2024 (UDI-DI 15099590209636), 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
United StatesGUDID listing GUDID Number15099590209636 UDI-DI Date11 Nov 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number150995901HEMACCESSORYP8 Basic UDI-DI 15099590209636UDI-DIDate28 Aug 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 150995901HEMACCESSORYP8 registered 28 Aug 2024 Active
  • FDA GUDID UDI-DI 15099590209636 listed 11 Nov 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED 150995901HEMACCESSORYP8
  2. Listed FDA GUDID 15099590209636

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  • Withdrawn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
Beckman Coulter DxH Slides EUDAMED
DxH GUDID
Generic name
General specimen microscopy slide IVD, single-use
Model / Ref / Catalog
B01276
Primary DI / UDI-DI
15099590209636
Basic UDI-DI
150995901HEMACCESSORYP8
Unit of use DI
05099590209639
FDA product code
LXG
EMDN code
W0503900201 Microscope slides
GMDN term
General specimen microscopy slide IVD, single-use
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2050
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
US-MF-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

Related devices

Category: General specimen microscopy slide IVD, single-use

Similar devices in this category

Other devices filed under MICROSCOPE SLIDES.

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

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