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STANDARD™ M10 Flu/RSV/SARS-CoV-2

by SD Biosensor Inc. United States EUDAMED

Ref 11FLU30AModel M10-CVFR-02

EMDN W0105070302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88001117IPBA01MA03WR Basic UDI-DIDate29 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Device Name
STANDARD™ M10 Flu/RSV/SARS-CoV-2 Fast
Model / Reference
M10-CVFR-02, 11FLU30A
Primary DI / UDI-DI
08800111722158
Basic UDI-DI
88001117IPBA01MA03WR
EMDN Code
W0105070302 Other virus combinations - multiplex na reagents
Device Class
Class B
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 & raw data

Show properties, registry sources and raw records
  • Microbial Substances
  • Near-Patient Testing
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08800111722158|88001117IPBA01MA03WR 61 fields · synced 24 Oct 2026