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Tricyclic antidepressant(TCA) Rapid Test(Urine)

by Safecare Biotech (Hangzhou) Co., Ltd.

Ref TCA-1011/TCA-1012/TCA-1014

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-697424646TCA001HRVB Basic UDI-DI D-697424646TCA001HRVBUDI-DIDate20 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
TCA-1011/TCA-1012/TCA-1014
Primary DI / UDI-DI
D-697424646TCA001HRVB
Basic UDI-DI
B-697424646TCA001HRVB
EMDN Code
W0102160599 Drugs of abuse/toxicology rt & poc - other
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000019109
Authorised representative
UnicareQ GmbH DE-AR-000051497

Other devices from Safecare Biotech (Hangzhou) Co., Ltd.

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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