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Total IgE Antibody Assay Kit (Colloidal Gold)

by Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd. EUDAMED

Active European Union

Ref 40 tests/box

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976045540020 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  • Withdrawn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

Model / Reference
40 tests/box
Primary DI / UDI-DI
06976045540020
Market of Registration
Austria

Manufacturer details

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

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