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Anti-dsDNA Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd.

Ref IM4422253, IM4410253, IM4415253Model IM4410253 IM4411253 IM4422253 IM4415253

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/IVDR NumberB-IM4422253JK Basic UDI-DI Date22 May 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-IM4422253JK Basic UDI-DI Date22 May 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Device Name
Anti-dsDNA Antibody Chemiluminescent Immunoassay Kit
Model / Reference
IM4422253, IM4410253 IM4411253 IM4422253 IM4415253, IM4410253, IM4415253
Primary DI / UDI-DI
D-IM4422253JK, 06950617402862, 06950617402886, 06950617402893
Basic UDI-DI
B-IM4422253JK, 69506174IM442253DZ
Direct Marketing DI
06950617402862
06950617402886
06950617402893
EMDN Code
W0102100105 Ds DNA - antibodies
Device Class
Class IVD General
Class B
EU market of registration
Germany
Spain

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
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No