Skip to content

CD20 [BC44]

by Biocare Medical United States EUDAMED

Ref API3316AAModel ACI3316A

EMDN W0102039099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08476270B331678 Basic UDI-DIDate7 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
ACI3316A, API3316AA
Primary DI / UDI-DI
00847627043146
Basic UDI-DI
08476270B331678
EMDN Code
W0102039099 Tumour markers - other
Device Class
Class C
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000034581
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Biocare Medical, LLC

See all devices from Biocare Medical, LLC →

Properties & raw data

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

Sources (1)

  • EUDAMED 00847627043146|08476270B331678 61 fields · synced 23 Oct 2026