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Total IgE Antibody Assay Kit (Colloidal Gold)

by Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd. FDA registration: China EUDAMED

Ref 100 tests/box EMDN W01020201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976045540037 Basic UDI-DIDate28 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  • Withdrawn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 24 Oct 2026

Model / Reference
100 tests/box
Primary DI / UDI-DI
06976045540037
Basic UDI-DI
B-06976045540037
EMDN Code
W01020201 Immunoglobulin e - total
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000055042
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.

See all devices from Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd. →

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 b7167821-a80f-4d76-8aaa-516f1047a3e7 61 fields · synced 24 Oct 2026