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Microbio Ltd

Active in EUDAMED

Australiafrom SRN EUDAMED SRN AU-MF-000033903

Microbio Ltd is a medical device manufacturer based in Australia, with 12 devices listed in EUDAMED (EU Class C) as of 14 Nov 2026.

Devices
12
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • EUDAMED 12
Device classes
  • EU Class C 12
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN AU-MF-000033903

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
Authorised rep.
Qualrep Services B.V.NL

What Microbio Ltd makes

Microbio Ltd manufactures a range of bacterial and yeast detection kits designed for bloodstream infection (BSI) diagnostics, including standalone bacterial and yeast assays as well as combined detection solutions. Their portfolio includes software for data analysis and reporting, integrated with the detection kits to streamline identification processes in clinical settings. The kits are intended for use in microbiology laboratories to identify pathogens rapidly, supporting sepsis management and antimicrobial stewardship.

The company’s products are classified as Class C medical devices under EU regulations and are listed in the EUDAMED database. Microbio Ltd operates from Australia, with its devices authorised for use within the European Economic Area through compliance with applicable medical device directives and regulations.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue12

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
AU-MF-000033903
EUDAMED status
Active
EUDAMED registered name
Microbio Ltd
Registered address
37, Kent Street, 4102, Woolloongabba, QLD, Australia
PRRC contact
Maryam Younes(public in EUDAMED)

From the company website

Read 18 Sep 2026

Welcome to Microbio, where we revolutionize pathogen detection with our InfectID-BSI technology. Discover how we enhance sepsis treatment and combat antimicrobial resistance through cutting-edge innovation.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Microbio Ltd have in the registry?

The registry currently lists 12 devices for Microbio Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Microbio Ltd's devices?

Among its 12 most recently registered devices, Microbio Ltd has devices listed in EUDAMED (12 devices).

What risk classes do Microbio Ltd's devices fall under?

Among its 12 most recently registered devices, the classes recorded for Microbio Ltd's devices are IVDR Class C. Each device page shows its own class and authorisation.

What are the newest devices from Microbio Ltd in the registry?

The most recently registered devices listed for Microbio Ltd include InfectID-BSI B3 Bacterial Detection Kit, InfectID-BSI B5 Bacterial Detection Kit, InfectID-BSI B1 Bacterial Detection Kit and InfectID-BSI Y1 Yeast Detection Kit.

Generated automatically from registry data and not verified by a human reviewer.