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SARS-CoV-2 IgG (CLIA)

by Maccura Biotechnology Co., Ltd. 4 variants

Ref EIM4405014, EIM4403014, EIM4402014, EIM4407014, EIM4408014, EIM4492014, EIM4406014

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-EIM4405014FW 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  • Withdrawn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 IgG (CLIA)
Model / Reference
EIM4405014, EIM4403014, EIM4402014, EIM4407014, EIM4408014, EIM4492014, EIM4406014
Primary DI / UDI-DI
D-EIM4405014FW, D-EIM4403014FG, D-EIM4402014F9, D-EIM4407014GC, D-EIM4408014GK, D-EIM4492014JC, D-EIM4406014G5
Basic UDI-DI
B-EIM4405014FW, B-EIM4403014FG, B-EIM4402014F9, B-EIM4407014GC, B-EIM4408014GK, B-EIM4492014JC, B-EIM4406014G5
EMDN Code
W0105040619
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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See all devices from Maccura Biotechnology Co., Ltd. →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (5)

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