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"Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)"

by Dirui Industrial Co., Ltd EUDAMED

Active European Union

Ref 3013807Model 50Tests/Kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06925794520319 Basic UDI-DIDate13 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

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

Specification

EUDAMED

Device Name
Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)
Model / Reference
50Tests/Kit, 3013807
Primary DI / UDI-DI
06925794520319
Basic UDI-DI
B-06925794520319
EMDN Code
W0102050205 Total human chorionic gonadotropin
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001891
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Dirui Industrial Co., Ltd

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

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