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David

by Equinox Biotech Co., Ltd. United States EUDAMED

Ref RH-MOP/MET/KET-C, RH-MOP/MET/KET-P, RH-MOP/MET/KET-CPModel dipcard, cassette and cup EMDN W0102160511

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69384449MOP/MET/KET014R Basic UDI-DIDate10 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
One Step MOP/MET/KET Screen Test (Urine)
Model / Reference
dipcard, cassette and cup, RH-MOP/MET/KET-C, RH-MOP/MET/KET-P, RH-MOP/MET/KET-CP
Primary DI / UDI-DI
D-69384449MOP/MET/KET014R
Basic UDI-DI
B-69384449MOP/MET/KET014R
EMDN Code
W0102160511 Multiple drugs of abuse/toxicology rt & poc
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018901
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Equinox Biotech Co., Ltd.

See all devices from Equinox Biotech Co., Ltd. →

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 82d44eba-93ea-4b32-942d-783e474c9943 61 fields · synced 22 Oct 2026