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1POT Duo

by 1drop Inc. South Korea EUDAMED

Ref PCMIAP

EMDN W0201069082,W02050382

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88000755PSAPSC Basic UDI-DIDate7 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
PCMIAP
Primary DI / UDI-DI
08800075500403
Basic UDI-DI
88000755PSAPSC
EMDN Code
W0201069082,W02050382
Device Class
Class A
Special Device Type
Software
Market of Registration
Italy

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
  • Near-Patient Testing
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08800075500403|88000755PSAPSC 61 fields · synced 24 Oct 2026