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QD-FAST Allergen Test Kit

by Jinan Deheng Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref IgE 1 test/kitModel 1gE 1 test/kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976612386006 Basic UDI-DIDate17 Jun 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
QD-FAST Allergen Test Kit
Model / Reference
1gE 1 test/kit, IgE 1 test/kit
Primary DI / UDI-DI
06976612386006
Basic UDI-DI
B-06976612386006
EMDN Code
W01020201,W01020204
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048173
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jinan Deheng Medical Technology Co., Ltd.

Properties

  • 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