Skip to content

Rse-B

by A3P Biomedical AB Sweden EUDAMED

Ref Index 08-0020

EMDN W0201020292

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08-0020TZ Basic UDI-DIDate21 Apr 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 22 Oct 2026

Model / Reference
Index 08-0020
Primary DI / UDI-DI
D-08-0020TZ
Basic UDI-DI
B-08-0020TZ
EMDN Code
W0201020292 Limited panel immunochemistry analysers - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000044967

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 92e5a407-5942-4110-be38-97bfdcf49a5d 61 fields · synced 22 Oct 2026