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SARS-CoV-2 Fluorescent PCR Kit

by Maccura Biotechnology Co., Ltd. 3 variants

Ref EGN7105110, EGN7102117, EGN7102109, EGN7101117, EGN7103117, EGN7101109

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 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-EGN7105110FC Basic UDI-DI Date22 May 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  • Withdrawn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
SARS-CoV-2 Fluorescent PCR Kit
SARS-CoV-2 Fluorescent PCR
Model / Reference
EGN7105110, EGN7102117, EGN7102109, EGN7101117, EGN7103117, EGN7101109
Primary DI / UDI-DI
D-EGN7105110FC, D-EGN7102117F5, D-EGN7102109F6, D-EGN7101117EW, D-EGN7103117FC, D-EGN7101109EX
Basic UDI-DI
B-EGN7105110FC, B-EGN7102117F5, B-EGN7102109F6, B-EGN7101117EW, B-EGN7103117FC, B-EGN7101109EX
EMDN Code
W0105040619, W0105040505
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

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