Skip to content

One-Step Drug of Abuse Test Tricyclic Antidepressants (TCA)

by W.H.P.M. Bioresearch & Technology Co., Ltd.

Ref WH-DU-S0x1201; WH-DU-S0x1202; WH-DU-S0x1203; WH-DU-S0x1204Model strip; cassette; dipcard; cup.

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-6909620WHDUSTCAMCT7 Basic UDI-DI D-6909620WHDUSTCAMCT7UDI-DIDate13 Mar 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Drugs of Abuse Tests (tricyclic antidepressants)
Model / Reference
strip, cassette, dipcard, cup., WH-DU-S0x1201, WH-DU-S0x1202, WH-DU-S0x1203, WH-DU-S0x1204
Primary DI / UDI-DI
D-6909620WHDUSTCAMCT7
Basic UDI-DI
B-6909620WHDUSTCAMCT7
EMDN Code
W0102160510 Tricyclic antidepressants - rt & poc
Device Class
Class IVD devices for self-testing
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000003007
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from W.H.P.M. Bioresearch & Technology Co., Ltd.

See all devices from W.H.P.M. Bioresearch & Technology Co., Ltd. →

Properties

  • Reagent
  • Self Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No