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Buprenorphine(BUP) Rapid Test

by VivaChek Biotech (Hangzhou) Co., Ltd.

Ref VDBUP-102, Buprenorphine(BUP) Rapid TestModel VDBUP-101

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-VDBUP-102JR Basic UDI-DI Date4 Dec 2024RegisteredStatusActive

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  • Withdrawn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
VDBUP-102, VDBUP-101, Buprenorphine(BUP) Rapid Test
Primary DI / UDI-DI
D-VDBUP-102JR, D-VDBUP-101JP
Basic UDI-DI
B-VDBUP-102JR, B-VDBUP-101JP
EMDN Code
W0102160599 Drugs of abuse/toxicology rt & poc - other
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000012160
Authorised representative
Lotus NL B.V. NL-AR-000000121

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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