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1drop™ TBIL

by 1drop Inc. South Korea EUDAMED

Ref 05400

EMDN W0201069082

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DSW-I02PLM 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 for T-BIL
Model / Reference
05400
Primary DI / UDI-DI
D-DSW-I02PLM
Basic UDI-DI
B-DSW-I02PLM
EMDN Code
W0201069082 Various rapid test chemistry / immunochemistry instruments - software accessories
Device Class
Class IVD General
Special Device Type
-1202
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
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED b033cbd7-aa55-401f-9c26-267a083de671 61 fields · synced 24 Oct 2026