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Automated PCR Analysis System

by FlashDx Shenzhen Inc 3 variants

Ref FlashDx® sSPRT™ 8TModel FlashDx® sSPRT™ 4T

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6974936202010408121UB Basic UDI-DIDate25 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
FlashDx® sSPRT™ 4T, FlashDx® sSPRT™ 8T
Primary DI / UDI-DI
06974936201067
Basic UDI-DI
6974936202010408121UB
Direct Marketing DI
06974936201067
EMDN Code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000025748
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties

  • 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