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PROTIA ANA Profile

by PROTIA Inc. South Korea EUDAMED

Ref PANP0112Model PROTIA ANA Profile 18

EMDN W0102100101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880944648ANP01JK Basic UDI-DIDate1 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
PROTIA ANA Profile 18, PANP0112
Primary DI / UDI-DI
08809446480627
Basic UDI-DI
880944648ANP01JK
Direct Marketing DI
08809446480627
EMDN Code
W0102100101 Ana screening
Device Class
Class B
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000026040
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from PROTIA Inc.

See all devices from PROTIA Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 2dee9da5-48ff-4c9d-b882-5711b39a57d3 61 fields · synced 22 Oct 2026