EUDAMED update: May 6, 2025

AusDiagnostics Pty Ltd

AU-MF-000020558

Active197 devices

Address: Coward Street, 290-292 2020 Mascot
Role: Manufacturer
Date of registration: Feb 21, 2022
Country: Australia

AusDiagnostics Pty Ltd is a medical device manufacturer registered in EUDAMED. The company has 197 devices on the EU market across 32 countries. Headquartered in Mascot, Australia. Explore the regulatory profile, devices and certificates on MD Atlas.

About AusDiagnostics

: AU-MF-000020558
Role: Manufacturer
Country: Australia
Organization name: AusDiagnostics Pty Ltd
EU VAT number: Not applicable
Trade register: 84 612 059 686
Date of registration: Feb 21, 2022

Contact details for AusDiagnostics

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

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Competent authority

Name: DE/CA23 - Regierungspräsidium Darmstadt Dezernat IV/Da 45.2

Phone: +49 (6151) 12 4001
Email: arbeitsschutz@rpda.hessen.de

Officers and regulatory representatives of AusDiagnostics

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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Connected operators

Importers

1 EU importer places this manufacturer's devices

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
CRE Reference 24-well	CRE Reference 24-well	`81099S`	`09343044004742`	1	On the market
Respiratory Pathogens C 16-well	Respiratory Pathogens C 16-well	`20613S`	`09343044001437`	1	On the market
Respiratory Pathogens C 16-well	Respiratory Pathogens C 16-well	`20613P`	`09343044001420`	1	On the market
RIDA®Prep Tissue Digestion Kit	RIDA®Prep Tissue Digestion Kit	`90241`	`09343044006197`	1	On the market
Step 1 tubes for Parasites 8-well	Step 1 tubes for Parasites 8-well	`85021S`	`09343044005688`	1	On the market
Atypical Pneumonia 8-well	Atypical Pneumonia 8-well	`20632P`	`09343044001567`	1	On the market
CRE 16-well	CRE 16-well	`21098S`	`09343044002205`	1	On the market
CRE 16-well	CRE 16-well	`21098P`	`09343044002199`	1	On the market
CRE EU 16-well	CRE EU 16-well	`21099S`	`09343044002656`	1	On the market
CRE EU 16-well	CRE EU 16-well	`21099P`	`09343044002649`	1	On the market
CRE Reference 24-well	CRE Reference 24-well	`81099P`	`09343044004735`	1	On the market
CSF 16-well	CSF 16-well	`27050P`	`09343044001949`	1	On the market
CSF 16-well	CSF 16-well	`27050S`	`09343044001956`	1	On the market
Demi DNA Reagent Cassette	Demi DNA Reagent Cassette	`40241`	`09343044003073`	1	On the market
Demi RNA Reagent Cassette	Demi RNA Reagent Cassette	`40341`	`09343044003110`	1	On the market
Dermatophytes and other Fungi 12-well	Dermatophytes and other Fungi 12-well	`84115S`	`09343044003349`	1	On the market
Dermatophytes and other Fungi 12-well	Dermatophytes and other Fungi 12-well	`84115P`	`09343044003332`	1	On the market
Extraction Control	Extraction Control	`91401`	`09343044002571`	1	On the market
Haemochromatosis 8-well	Haemochromatosis 8-well	`23156P`	`09343044002328`	1	On the market
Haemochromatosis 8-well	Haemochromatosis 8-well	`23156S`	`09343044002335`	1	On the market
High Risk HPV Genotyping 8-well	High Risk HPV Genotyping 8-well	`23201S`	`09343044002434`	1	On the market
High Risk HPV Genotyping 8-well	High Risk HPV Genotyping 8-well	`23201P`	`09343044002427`	1	On the market
HighPlex Ascend System	HighPlex Ascend System	`96501`	`09343044005831`	1	On the market
HighPlex System	HighPlex System	`91501`	`09343044002298`	1	On the market
Low DNA Reagent Cassette	Low DNA Reagent Cassette	`40231`	`09343044003080`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
CRE Reference 24-well	CRE Reference 24-well	`81099S`	`09343044004742`	1	On the market
Respiratory Pathogens C 16-well	Respiratory Pathogens C 16-well	`20613S`	`09343044001437`	1	On the market
Respiratory Pathogens C 16-well	Respiratory Pathogens C 16-well	`20613P`	`09343044001420`	1	On the market
RIDA®Prep Tissue Digestion Kit	RIDA®Prep Tissue Digestion Kit	`90241`	`09343044006197`	1	On the market
Step 1 tubes for Parasites 8-well	Step 1 tubes for Parasites 8-well	`85021S`	`09343044005688`	1	On the market
Atypical Pneumonia 8-well	Atypical Pneumonia 8-well	`20632P`	`09343044001567`	1	On the market
CRE 16-well	CRE 16-well	`21098S`	`09343044002205`	1	On the market
CRE 16-well	CRE 16-well	`21098P`	`09343044002199`	1	On the market
CRE EU 16-well	CRE EU 16-well	`21099S`	`09343044002656`	1	On the market
CRE EU 16-well	CRE EU 16-well	`21099P`	`09343044002649`	1	On the market
CRE Reference 24-well	CRE Reference 24-well	`81099P`	`09343044004735`	1	On the market
CSF 16-well	CSF 16-well	`27050P`	`09343044001949`	1	On the market
CSF 16-well	CSF 16-well	`27050S`	`09343044001956`	1	On the market
Demi DNA Reagent Cassette	Demi DNA Reagent Cassette	`40241`	`09343044003073`	1	On the market
Demi RNA Reagent Cassette	Demi RNA Reagent Cassette	`40341`	`09343044003110`	1	On the market
Dermatophytes and other Fungi 12-well	Dermatophytes and other Fungi 12-well	`84115S`	`09343044003349`	1	On the market
Dermatophytes and other Fungi 12-well	Dermatophytes and other Fungi 12-well	`84115P`	`09343044003332`	1	On the market
Extraction Control	Extraction Control	`91401`	`09343044002571`	1	On the market
Haemochromatosis 8-well	Haemochromatosis 8-well	`23156P`	`09343044002328`	1	On the market
Haemochromatosis 8-well	Haemochromatosis 8-well	`23156S`	`09343044002335`	1	On the market
High Risk HPV Genotyping 8-well	High Risk HPV Genotyping 8-well	`23201S`	`09343044002434`	1	On the market
High Risk HPV Genotyping 8-well	High Risk HPV Genotyping 8-well	`23201P`	`09343044002427`	1	On the market
HighPlex Ascend System	HighPlex Ascend System	`96501`	`09343044005831`	1	On the market
HighPlex System	HighPlex System	`91501`	`09343044002298`	1	On the market
Low DNA Reagent Cassette	Low DNA Reagent Cassette	`40231`	`09343044003080`	1	On the market

AusDiagnostics Pty Ltd

About AusDiagnostics

Contact details for AusDiagnostics

Export the 197 devices of AusDiagnostics

Competent authority

Officers and regulatory representatives of AusDiagnostics

Connected operators

Importers

Related searches

About AusDiagnostics

Contact details for AusDiagnostics

Export the 197 devices of AusDiagnostics

Competent authority

Officers and regulatory representatives of AusDiagnostics

Statistics for AusDiagnostics

Certificate health for AusDiagnostics

Devices by risk class

Market presence of AusDiagnostics

Device catalog for AusDiagnostics

Device families (Basic UDI-DI) of AusDiagnostics

Connected operators

Importers

Related searches

Market presence of AusDiagnostics

Devices by risk class

Certificate health for AusDiagnostics

Statistics for AusDiagnostics

Device catalog for AusDiagnostics

Device families (Basic UDI-DI) of AusDiagnostics