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Detection Kit for 2019-nCoV (PCR-Fluorescence)

by Daan Gene Co., Ltd. China EUDAMED

Ref DA0995Model Single tube, 96 tests/kit EMDN W0105040599

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06928103009956 Basic UDI-DIDate21 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Detection Kit for 2019-nCoV (PCR-Fluorescence)
Model / Reference
Single tube, 96 tests/kit, DA0995
Primary DI / UDI-DI
06928103009956
Basic UDI-DI
B-06928103009956
EMDN Code
W0105040599 Virology - na reagents - other
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000025799
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Daan Gene Co., Ltd.

See all devices from Daan Gene Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 15ed30b2-53e3-4419-99c0-5e8ab4394dd0 61 fields · synced 24 Oct 2026