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Allergen-Specific IgE Antibody Quality Control

by Shenzhen Dymind Biotechnology Co., Ltd. China EUDAMED

Ref MY-0033-01Model Specification 7: Control 1: 1×0.5 mL, control 2: 1×0.5 mL,Control 3: 1×0.5 mL, control 4: 1×0.5 mL EMDN W01021521

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976117454989 Basic UDI-DIDate8 Jun 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  • Withdrawn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
Specification 7: Control 1: 1×0.5 mL, control 2: 1×0.5 mL, Control 3: 1×0.5 mL, control 4: 1×0.5 mL, MY-0033-01
Primary DI / UDI-DI
06976117454989
Basic UDI-DI
B-06976117454989
EMDN Code
W01021521 Multicomponent immunochemistry controls
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000024842
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Shenzhen Dymind Biotechnology Co., Ltd.

See all devices from Shenzhen Dymind Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (5)
  • Sterile: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06976117454989|B-06976117454989 61 fields · synced 25 Oct 2026