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HEV IgG Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. 5 variants

Ref IM4406017Model IM4402017 IM4403017 IM4406017 IM4407017 EIM4492017

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-IM4406017JB Basic UDI-DI Date22 May 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-IM4406017JB 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  • Withdrawn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
HEV IgG Antibody Chemiluminescent Immunoassay Kit
HEV IgG Chemiluminescent Immunoassay Kit
Model / Reference
IM4406017, IM4402017 IM4403017 IM4406017 IM4407017 EIM4492017
Primary DI / UDI-DI
D-IM4406017JB, 06950617415800
Basic UDI-DI
B-IM4406017JB, 69506174IM440017D5
Direct Marketing DI
06950617415800
EMDN Code
W0105020504 Hev antibody igg
Device Class
Class IVD General
Class B
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Humiss International B.V. NL-AR-000001490

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties

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

Other properties (6)

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