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BrightVision

by WellMed BV Netherlands EUDAMED

Ref c-B500HRP-BGX EMDN W01029003

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number872081305c-B500HRP-BGXXP Basic UDI-DIDate13 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Detection system
Model / Reference
c-B500HRP-BGX
Primary DI / UDI-DI
08720813052110
Basic UDI-DI
872081305c-B500HRP-BGXXP
EMDN Code
W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000023115

Other devices from WellMed BV

See all devices from WellMed BV →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED f70fe643-acb9-46d4-892f-84df66a1fb54 61 fields · synced 24 Oct 2026