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Respiratory Pathogens 16-well

by AusDiagnostics Pty Ltd 2 variants

Ref 20620P

Active European Union

CE IVDD

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/IVDD NumberB-09343044004179 Basic UDI-DI 09343044004179UDI-DIDate24 Oct 2023RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Step 2 Plates for Respiratory Pathogens 16-well
Model / Reference
20620P
Primary DI / UDI-DI
09343044004179
Basic UDI-DI
B-09343044004179
EMDN Code
W0105070503 Respiratory tract infections - multiplex na reagents
Device Class
Class IVD General
EU market of registration
Malta

Manufacturer details

EUDAMED SRN
AU-MF-000020558
Authorised representative
Advena Limited MT-AR-000000234

From the manufacturer

Manufacturer's product page: Respiratory Pathogens

Other devices from AusDiagnostics Pty Ltd

See all devices from AusDiagnostics Pty Ltd →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No