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STANDARD™ i Trigger

by SD Biosensor Inc.

Ref 16TR10Model i-TRG-01

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88001117IPAA06IA01WV Basic UDI-DI 08800111722684UDI-DIDate27 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
i-TRG-01, 16TR10
Primary DI / UDI-DI
08800111722684
Basic UDI-DI
88001117IPAA06IA01WV
Direct Marketing DI
08800111724374
EMDN Code
W0201020185 Automated immunochemistry analysers - consumables
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000009168
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties

  • 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