Skip to content

RF-IgA Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd.

Ref IM4402271Model IM4402271 IM4403271 IM4406271 IM4407271 IM4410271 IM4411271 IM4414271 IM4415271

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 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/IVDD NumberB-IM4402271HX 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
RF-IgA Chemiluminescent Immunoassay Kit
Model / Reference
IM4402271, IM4402271 IM4403271 IM4406271 IM4407271 IM4410271 IM4411271 IM4414271 IM4415271
Primary DI / UDI-DI
D-IM4402271HX, 06950617433736
Basic UDI-DI
B-IM4402271HX, 69506174IM440271DM
Direct Marketing DI
06950617433736
EMDN Code
W01021110, W01021199
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 YesEUDAMEDNoEUDAMED
  • 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