Skip to content

Total Immunoglobulin E (Total IgE) Test Kit (Immunofluorescence)

by Genrui Biotech Inc. China EUDAMED

Ref 52026210 EMDN W01020201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06950334815891 Basic UDI-DIDate30 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
52026210
Primary DI / UDI-DI
06950334815891
Basic UDI-DI
B-06950334815891
EMDN Code
W01020201 Immunoglobulin e - total
Device Class
Class IVD General
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000017351
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Genrui Biotech Inc.

See all devices from Genrui Biotech Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06950334815891|B-06950334815891 61 fields · synced 25 Oct 2026