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Multi-Drug Test (Saliva)

by Hangzhou Clongene Biotech Co., Ltd. EUDAMED

Active European Union

Ref DDOA7205,DDOA7305, DDOA7405,DDOA7505,DDOA7605,DDOA7707,DDOA7807,DDOA7907,DDOA7a07, DDOA7b07, DDOA7b65, DDOA7c07, etc.Model Midstream/Cassette/Cup

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DDOA718SZ Basic UDI-DIDate6 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
Midstream/Cassette/Cup, DDOA7205, DDOA7305, DDOA7405, DDOA7505, DDOA7605, DDOA7707, DDOA7807, DDOA7907, DDOA7a07, DDOA7b07, DDOA7b65, DDOA7c07, etc.
Primary DI / UDI-DI
D-DDOA718SZ
Basic UDI-DI
B-DDOA718SZ
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-000030069
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Hangzhou Clongene Biotech 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