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BioLINE Allergy Reagent Kit

by HOB Biotech Group Corp., Ltd. China EUDAMED

Ref MB00268Model FD-1, 24 Tests/Kit EMDN W01020204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06924030412517 Basic UDI-DIDate23 Aug 2024RegisteredStatusActive

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  • Withdrawn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
FD-1, 24 Tests/Kit, MB00268
Primary DI / UDI-DI
06924030412517
Basic UDI-DI
B-06924030412517
EMDN Code
W01020204 Immunoglobulin e - monotest/pluriresult-multi ag
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000023974
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from HOB Biotech Group Corp., Ltd.

See all devices from HOB Biotech Group Corp., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 29c8c1be-87e1-49e5-9d04-ff20dbd1fa47 61 fields · synced 24 Oct 2026