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BioCLIA Autoimmune Reagent Kit, IgG4

by HOB Biotech Group Corp., Ltd. China EUDAMED

Ref MY02291Model BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set EMDN W0102010106

Regulatory status

as of 26 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

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, MY02291
Primary DI / UDI-DI
06924030416966
Basic UDI-DI
6924030BioCLIAAI3N
Direct Marketing DI
06924030416966
EMDN Code
W0102010106 Immunoglobulin g subclass reagents
Device Class
Class B
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.

See all devices from HOB Biotech Group Corp., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06924030416966|6924030BIOCLIAAI3N 61 fields · synced 25 Oct 2026