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Multi-Drug Tests

by Hangzhou Clongene Biotech Co., Ltd. EUDAMED

Active European Union

Ref DDOA1704,DDOA1707,DDOA1804,DDOA1a55,DDOA1b04,DDOA1c04,DDOA1fd4,DDOA1hf7,DDOA1g04,DDOA1h04,DDOA1i04,DDOA1ie7, etc.Model Cassette/Dip Card/Easy Cup/Split Key Cup

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DDOA138S9 Basic UDI-DIDate25 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
Cassette/Dip Card/Easy Cup/Split Key Cup, DDOA1704, DDOA1707, DDOA1804, DDOA1a55, DDOA1b04, DDOA1c04, DDOA1fd4, DDOA1hf7, DDOA1g04, DDOA1h04, DDOA1i04, DDOA1ie7, etc.
Primary DI / UDI-DI
D-DDOA138S9
Basic UDI-DI
B-DDOA138S9
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