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Bio-Instant

by Hangzhou ELIT Biotech Co., Ltd.

Ref EDOA-124~1144Model 25T/kit

Active European Union

CE IVDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697666795DOAZ8 Basic UDI-DI 06976667950030UDI-DIDate14 Jul 2026RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Multi-Drug Rapid Test 14 Drugs in 1 Combo Panel (OPI2000/MDMA500/MOP300/OXY100/MTD300/PCP25/COC300/AMP1000/MET1000/BAR300/EDDP100/THC50/BZO300/BUP10)
Model / Reference
25T/kit, EDOA-124~1144
Primary DI / UDI-DI
06976667950030
Basic UDI-DI
697666795DOAZ8
EMDN Code
W0102160511 Multiple drugs of abuse/toxicology rt & poc
Device Class
Class B
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000043511
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

Other devices from Hangzhou ELIT Biotech Co., Ltd.

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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