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STANDARD™ F2400 Analyzer

by SD Biosensor Inc. United States EUDAMED

Ref 10FA24Model F2400 EMDN W0201069099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88001117IPAA01FA03UM Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
F2400, 10FA24
Primary DI / UDI-DI
08800111723759, 08800111723766, 08800111723797, 08800111723773, 08800111700118, 08800111723872, 08800111700125, 08800111723803, 08800111723858, 08800111721076, 08800111723834, 08800111723827, 08800111700132, 08800111723841
Basic UDI-DI
88001117IPAA01FA03UM
Direct Marketing DI
08809319399933
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class A
Market of Registration
Portugal
Germany
Denmark
Finland
Italy
Estonia
Spain
Norway
Romania
Poland
Czechia
France
Slovakia

Manufacturer details

EUDAMED SRN
KR-MF-000009168
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sd Biosensor, Inc.

See all devices from Sd Biosensor, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (14)

  • EUDAMED 6fcd9394-7d25-4c89-9207-e98e20dd45ad 61 fields · synced 24 Oct 2026
  • EUDAMED 08800111723766|88001117IPAA01FA03UM 61 fields · synced 19 Jun 2026
  • EUDAMED 08800111723797|88001117IPAA01FA03UM 61 fields · synced 19 Jun 2026
  • EUDAMED 08800111723773|88001117IPAA01FA03UM 61 fields · synced 19 Jun 2026
  • EUDAMED 08800111700118|88001117IPAA01FA03UM 61 fields · synced 11 Jul 2026
  • EUDAMED 08800111723872|88001117IPAA01FA03UM 61 fields · synced 15 Jul 2026
  • EUDAMED 08800111700125|88001117IPAA01FA03UM 61 fields · synced 20 Jul 2026
  • EUDAMED 08800111723803|88001117IPAA01FA03UM 61 fields · synced 21 Jul 2026
  • EUDAMED 08800111723858|88001117IPAA01FA03UM 61 fields · synced 23 Jul 2026
  • EUDAMED 08800111721076|88001117IPAA01FA03UM 61 fields · synced 24 Jul 2026
  • EUDAMED 08800111723834|88001117IPAA01FA03UM 61 fields · synced 24 Jul 2026
  • EUDAMED 08800111723827|88001117IPAA01FA03UM 61 fields · synced 24 Jul 2026
  • EUDAMED 08800111700132|88001117IPAA01FA03UM 61 fields · synced 4 Aug 2026
  • EUDAMED 08800111723841|88001117IPAA01FA03UM 61 fields · synced 5 Oct 2026