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Digival EQ00600X

by Alere Scarborough, Inc.

Ref LFR-000

Digival EQ00600X is a Class A device made by Alere Scarborough, Inc., registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI 081187701DGV00012M), cleared under FDA 510(k) K162642 on 10 Apr 2017 and listed in FDA GUDID since 8 Jul 2019 (UDI-DI 00811877010623), active as of 24 Oct 2026.

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

CE IVDR 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) K162642

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/IVDR EUDAMED Number081187701DGV00012M Basic UDI-DI 00811877010623UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00811877010623 UDI-DI Date8 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162642 Date10 Apr 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081187701DGV00012M registered 16 Oct 2026 Active
  • FDA 510(k) K162642 decided 10 Apr 2017 Active
  • FDA GUDID UDI-DI 00811877010623 listed 8 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162642
  2. Listed FDA GUDID 00811877010623
  3. Registered EUDAMED 081187701DGV00012M

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Digival™ EUDAMED
Digival GUDID
Generic name
Photometric/spectroscopic immunoassay analyser IVD
Device name
Digival™ (Ous)
Model / reference
LFR-000 EUDAMED
EQ00600X GUDID
Primary DI / UDI-DI
00811877010623
Basic UDI-DI
081187701DGV00012M
510(k) Number
EMDN code
W0201020201 Immunochemistry readers
GMDN term
Photometric/spectroscopic immunoassay analyser IVD
Device class
Class A
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
LFR-000
GUDID
EQ00600X

Related devices

Category: Photometric/spectroscopic immunoassay analyser IVD

Cleared under the same submission (K162642)

and 1 more cleared under K162642

Similar devices in this category

Other devices filed under IMMUNOCHEMISTRY READERS.

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Properties

  • IVD kit
  • Professional testing
  • IVD instrument
  • Convenience kit
  • Serial number
Other properties (21, all answered No)