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AD Nucléis direct SARS-CoV-2_1-step RTCPR 48R

by AD Nucleis EUDAMED

Active European Union

Ref HQS_DICoV2_IVD48RModel AD Nucléis direct SARS-CoV-2_1-step RTCPR

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-37604277000196 Basic UDI-DIDate15 Jul 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  • Withdrawn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
AD Nucléis direct SARS-CoV-2_1-step RTCPR, HQS_DICoV2_IVD48R
Primary DI / UDI-DI
37604277000196
Basic UDI-DI
B-37604277000196
EMDN Code
W0105041106 Coronavirus - na reagents
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000002215

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See all devices from AD Nucleis →

Properties

  • 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