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SARS-CoV-2, Influenza and RSV 8-well

EUDAMED

Class IVD General (EU MDR)

Ref 80081SRef 80081P

by AusDiagnostics Pty Ltd

Identity

Trade Name
SARS-CoV-2, Influenza and RSV 8-well EUDAMED
RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 1 EUDAMED
RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well Step 2 EUDAMED
Device Name
Step 1 tubes for SARS-CoV-2, Influenza and RSV 8-well EUDAMED
RIDA®Plex SARS-CoV-2, Influenza and RSV 8 well EUDAMED
Model / Reference
80081S EUDAMED
80081P EUDAMED

Identifiers

Primary DI / UDI-DI
09343044002762 EUDAMED
09343044007118 EUDAMED
09343044006630 EUDAMED
Basic UDI-DI
B-09343044002762 EUDAMED
B-09343044007118 EUDAMED
B-09343044006630 EUDAMED
EMDN Code
W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Malta EUDAMED
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

SARS-CoV-2, Influenza and RSV 8-well by AusDiagnostics Pty Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
AusDiagnostics Pty Ltd
EUDAMED SRN
AU-MF-000020558
Authorised Representative
Advena Limited MT-AR-000000234

Sources (3)

  • EUDAMED 55ffa0c0-2c78-4d88-ad47-98e739e40db2 61 fields · synced Jul 22, 2026
  • EUDAMED 60c1e4d2-405a-428e-afec-b2b201566792 61 fields · synced May 18, 2026
  • EUDAMED d5702631-1b3c-4524-816a-5869d12d3ef7 61 fields · synced May 19, 2026