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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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AusDiagnostics Pty Ltd — Manufacturer in Australia

EUDAMED update: May 6, 2025

AP

AusDiagnostics Pty Ltd

Australia

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Sources: EUDAMED

Legal information of AusDiagnostics

Legal name: AusDiagnostics Pty Ltd
EU VAT number: Not applicable
Trade register: 84 612 059 686
SRN (displayed role): AU-MF-000020558
EUDAMED status: Active· registered in 2022
Registered office: Coward Street, 290-292 2020 Mascot, Australia

Contact details for AusDiagnostics

Phone: +61296988030
Email: regulatory@r-biopharm.com.au
Website: www.ausdiagnostics.com
Address: 290-292, COWARD STREET 2020 MASCOT AUSTRALIA

Data export

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Competent authority for AusDiagnostics

DE/CA23 - Regierungspräsidium Darmstadt Dezernat IV/Da 45.2
GermanyContact the authority →

Market presence of AusDiagnostics

Devices placed in 32 countries

Risk categories of AusDiagnostics

Executives & regulatory representatives of AusDiagnostics

2 contacts identified

PRRC
FERNANDES Jennifer
1) Ensuring the conformity of the devices is correct in accordance with the Quality Management System prior to release. 2) The technical documentation and Declaration of Conformity are drawn up and kept up to date. 3) The The Post Market Surveillance obligations are complied with. 4) The reporting obligations are fulfilled.
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FERNANDES Jennifer

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Cartography of AusDiagnostics

Authorised representativePeople

R-Biopharm AG — represents — AusDiagnostics
Advena Limited — represents — AusDiagnostics
FERNANDES Jennifer — AusDiagnostics

Certificates of AusDiagnostics

No certificates registered for this manufacturer.

200Total Devices

162Basic UDI-DIs

0Certificates0 valid · 0 expiring < 12 months

32CountriesEU/EEA placements

Catalog of AusDiagnostics

200 devices · 167 families

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Step 1 tubes for Viral CSF (8-well)1 version
Step 2 Plates for Viral CSF (8-well)1 version
Step 1 tubes for Atypical Pneumonia (8-well)1 version
Step 1 tubes for Pneumonia (16-well)1 version
Step 2 Plates for Pneumonia (16-well)1 version
Step 1 tubes for Urinogenital (8-well)1 version
Step 2 Plates for Urinogenital (8-well)1 version
Step 1 tubes for STI (16-well)1 version
Step 2 Plates for STI (16-well)1 version
Step 1 tubes for Urinogenital and Resistance 12-well1 version
Step 2 Plates for Urinogenital and Resistance 12-well1 version
Step 1 tubes for Urinogenital and Resistance 12 well1 version
Step 2 Plates for Urinogenital and Resistance 12 wellMultiple sexually transmitted pathogen (Annex II) nucleic acid IVD, reagent1 version
Step 1 tubes for Viral Panel 12-well1 version
Step 2 Plates for Viral Panel 12-well1 version
Step 1 tubes for Herpes, Enterovirus and Adenovirus 8-well1 version
Step 2 Plates for Herpes, Enterovirus and Adenovirus 8-well1 version
Synthetic Positive Controls for Atypical Pneumonia1 version
Step 2 Plates for Atypical Pneumonia 8-well1 version
Synthetic Positive Controls for CSF1 version
Step 1 tubes for Vaginitis and vaginosis 8-well 1 version
Step 2 Plates for Vaginitis and vaginosis 8-well1 version
Step 2 Plates for Vaginitis and vaginosis 12-well1 version
Step 1 tubes for Vaginitis and vaginosis 12-well1 version
Step 2 Plates for High Risk HPV Genotyping 8-well1 version

167 families

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