Skip to content

Body Fluid-I

by R&D Systems, Inc. United States EUDAMED

Ref 0BI202TA3

EMDN W0103010503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00815762026393 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Bfa
Model / Reference
0BI202TA3
Primary DI / UDI-DI
00815762026393
Basic UDI-DI
B-00815762026393
EMDN Code
W0103010503 Multilevel blood controls
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000024485
Authorised representative
BIO-TECHNE SAS FR-AR-000011963

Other devices from R&D Systems, Inc.

See all devices from R&D Systems, Inc. →

Properties & raw data

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

Sources (1)

  • EUDAMED 00815762026393|B-00815762026393 61 fields · synced 24 Oct 2026