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ARK HS Opiate Calibrator

by ARK Diagnostics, Inc. United States EUDAMED

Ref 5037-0002-01Model 5037-0001-00 EMDN W0102152209

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0858724003OPI03769 Basic UDI-DIDate19 Oct 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  • Withdrawn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 25 Oct 2026

Device Name
ARK HS Opiate Assay
Model / Reference
5037-0001-00, 5037-0002-01
Primary DI / UDI-DI
00812101031810
Basic UDI-DI
0858724003OPI03769
Direct Marketing DI
00812101031810
EMDN Code
W0102152209 Drugs of abuse / toxicology standards and calibrators
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 & 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 00812101031810|0858724003OPI03769 61 fields · synced 25 Oct 2026