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BioCLIA Autoimmune Reagent Kit, MDA5 (Chemiluminescent Microparticle Immunoassay)

by HOB Biotech Group Corp., Ltd.

Ref MY02288Model BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set

Active European Union

CE IVDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6924030BioCLIAAI3N Basic UDI-DI 06924030417031UDI-DIDate23 Aug 2024RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set
Model / Reference
BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set, MY02288
Primary DI / UDI-DI
06924030417031
Basic UDI-DI
6924030BioCLIAAI3N
Direct Marketing DI
06924030417031
EMDN Code
W0102100199 Autoimmune connective tissue diseases testing - other
Device Class
Class B
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000023974
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from HOB Biotech Group Corp., Ltd.

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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