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1drop™ Hemo

by 1drop Inc. South Korea EUDAMED

Ref H18290Model H18

EMDN W010106010801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800075500328 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™ Hemo Hemoglobin Control Solution
Model / Reference
H18, H18290
Primary DI / UDI-DI
08800075500328
Basic UDI-DI
B-08800075500328
EMDN Code
W010106010801 Blood test strips controls
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
  • 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 2284f210-57af-447b-a750-bc124988c1c9 61 fields · synced 24 Oct 2026