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1drop™ TBIL

by 1drop Inc. South Korea EUDAMED

Ref B2019015TModel B20

EMDN W0101060199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-B2019015TWG Basic UDI-DIDate31 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
1drop™ TBIL Total Bilirubin Test Cartridges
Model / Reference
B20, B2019015T
Primary DI / UDI-DI
D-B2019015TWG
Basic UDI-DI
B-B2019015TWG
EMDN Code
W0101060199 Blood test strips (cc) - rapid tests and "point of care" - other
Device Class
Class IVD General
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
KR-MF-000026103
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from 1drop Inc.

See all devices from 1drop Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED D-B2019015TWG|B-B2019015TWG 61 fields · synced 24 Oct 2026