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ARK HS Benzodiazepine II Assay

by ARK Diagnostics, Inc. EUDAMED

Active European Union

Ref 5073-0001-03Model 5073-0001-00

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0858724003BZD0733F Basic UDI-DIDate3 Apr 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  • Withdrawn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

Model / Reference
5073-0001-00, 5073-0001-03
Primary DI / UDI-DI
00812101032183
Basic UDI-DI
0858724003BZD0733F
Direct Marketing DI
00812101032183
EMDN Code
W0102090104 Benzodiazepines
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000023925
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Ark Diagnostics Inc

See all devices from Ark Diagnostics Inc →

Properties

  • 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