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IDSys Elite

by ASTA Corporation South Korea EUDAMED

Ref MMS-EB-03Model IDSys Elite

EMDN W02030199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number880989219MMSEVC Basic UDI-DIDate4 Jun 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
IDSys Elite, MMS-EB-03
Primary DI / UDI-DI
08809892190026, 08809892190170
Basic UDI-DI
880989219MMSEVC, 880989219MMSEB0394
EMDN Code
W02030199, W020303
Device Class
Class A
Class C
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000051737
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from ASTA Corporation

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
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
  • New Device: No

Sources (2)

  • EUDAMED 7345fe58-6afc-447b-8af1-fd4e557546f9 61 fields · synced 24 Oct 2026
  • EUDAMED 08809892190170|880989219MMSEB0394 61 fields · synced 17 Oct 2026