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2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)

by Jiangsu Mole Bioscience Co., LTD. 11 variants

Ref R401T008B0C2

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDD NumberB-06970895476201 Basic UDI-DI 06970895476201UDI-DIDate9 Nov 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
2019-Novel Coronavirus Mutants Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)
Model / Reference
R401T008B0C2
Primary DI / UDI-DI
06970895476201
Basic UDI-DI
B-06970895476201
EMDN Code
W0105041106 Coronavirus - na reagents
Device Class
Class IVD General
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000001539
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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