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BrightDAB

by WellMed BV Netherlands EUDAMED

Ref BS04-11, BS04-500, BS04-999 EMDN W01029003

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number872081305BS04-11WW Basic UDI-DIDate7 Jun 2022RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Substrates
Model / Reference
BS04-11, BS04-500, BS04-999
Primary DI / UDI-DI
08720813050888, 08720813050895, 08720813050901
Basic UDI-DI
872081305BS04-11WW, 872081305BS04-5002D, 872081305BS04-9994E
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
  • New Device
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

Sources (3)

  • EUDAMED 43a85ae9-7b93-4129-906d-979bd985023b 61 fields · synced 22 Oct 2026
  • EUDAMED 08720813050895|872081305BS04-5002D 61 fields · synced 17 May 2026
  • EUDAMED 08720813050901|872081305BS04-9994E 61 fields · synced 18 May 2026