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DENSICHEK® Plus 21250

by Biomerieux, Inc.

Ref 21250

DENSICHEK® Plus 21250 is a device classified as IVD General (EU), Class II (US) made by Biomerieux, Inc., registered in EUDAMED on 9 Sep 2026 (Basic UDI-DI B-03573026222239), cleared under FDA 510(k) K083536 on 11 Sep 2009 and listed in FDA GUDID since 30 Nov 2016 (UDI-DI 03573026222239), active as of 24 Oct 2026.

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

CE IVDD 510(k)

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 linked in EUDAMED

A group certificate may exist

510(k) K083536

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/IVDD EUDAMED NumberB-03573026222239 Basic UDI-DI 03573026222239UDI-DIDate9 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03573026222239 UDI-DI Date30 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083536 Date11 Sep 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03573026222239 registered 9 Sep 2026 Active
  • FDA 510(k) K083536 decided 11 Sep 2009 Active
  • FDA GUDID UDI-DI 03573026222239 listed 30 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083536
  2. Listed FDA GUDID 03573026222239
  3. Registered EUDAMED B-03573026222239

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
DENSICHEK® Plus
Generic name
Photometer, absorbance/transmission, automated
Model / reference
21250
Primary DI / UDI-DI
03573026222239
Basic UDI-DI
B-03573026222239
510(k) Number
FDA product code
LON
EMDN code
W02039099 Various microbiology instruments - other
GMDN term
Photometer, absorbance/transmission, automated
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
866.1645
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General 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: Photometer, absorbance/transmission, automated

Cleared under the same submission (K083536)

Similar devices in this category

Other devices filed under VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER.

Other devices from Biomerieux, Inc.

See all devices from Biomerieux, Inc. →

Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
Other properties (22, all answered No)