Multiplex viral antigen test
IVD Class 3
For combined respiratory virus antigen testing. The certificate lists different combinations and settings including self-testing and point-of-care use.
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Sonictec's team submitted these projects on behalf of clients. The Sponsor named on a certificate may be Sonictec or another entity appointed by the client. Submission support and the Sponsor's legal responsibilities are distinct roles.
To protect clients and manufacturers, public documents conceal manufacturers, brands and registration numbers that could identify them, while retaining product classes and certificate conditions. Case numbers are site references only. Retained certificates reflect their content at the time and do not prove current validity or product efficacy.
Portable ultrasound imaging system
MD Class IIa
A battery-powered handheld ultrasound imaging system for acquiring, displaying and analysing ultrasound information. Refer to the certificate for configurations and scope.
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Endoscope cleaning brush
MD Class I
A brush accessory for cleaning endoscope channels.
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Gastrointestinal endoscopic haemostatic clip
MD Class IIb
A long-term indwelling clip device for closure and haemostasis during gastrointestinal endoscopy. Refer to the certificate for locations and indications.
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Multiplex viral test
IVD Class 3
An in vitro diagnostic product for respiratory viruses. Refer to the certificate for specific tests, specimens and use settings.
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Subcutaneous glucose sensor
MD Class I · Export Only
Used with a compatible glucose monitoring system to continuously monitor glucose levels in people with diabetes. This certificate is an export-only entry.
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Dental ceramic
MD Class IIa
Ceramic blanks for custom dental restorations such as crowns, bridges, veneers, inlays and onlays.
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Multiplex viral nucleic acid test
IVD Class 3
An IVD reagent for qualitative detection of SARS-CoV-2 and influenza A and B viral nucleic acids. Refer to the certificate for specimen types.
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Endoscopic carbon dioxide tubing
MD Class IIa
Tubing for delivery of carbon dioxide during endoscopy. The certificate describes filtration and prevention of fluid backflow.
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SARS-CoV-2 antigen self-test
IVD Class 3
For lay users to test for SARS-CoV-2 using a nasal swab, assisting diagnostic assessment in symptomatic individuals.
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Endoscopic insufflation connector
MD Class IIa
An adapter connecting carbon dioxide tubing to a gas source. The certificate limits intended use to no more than 24 hours.
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SARS-CoV-2 antigen self-test
IVD Class 3
For SARS-CoV-2 antigen self-testing by lay users with nasal swab specimens.
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Fluorescence immunoassay analyser
IVD Class 1
Used with dry reagents based on fluorescence immunochromatography to quantitatively or semi-quantitatively detect specified analytes in biological specimens.
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Listed medicine — NE1-Elite
AUST L
A listed medicine with recorded indications relating to post-exercise recovery and support for muscle discomfort. Refer to the certificate for applicable indications and warnings.
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Listed medicine — NE1-Heart
AUST L
A listed medicine with recorded indications relating to heart health support. Refer to the certificate for applicable indications and warnings.
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General-use protective mask
MD Class I
Covers the nose and mouth and filters particles for respiratory protection. The certificate defines its scope of use.
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Medical face shield · 01
MD Class I
Worn by healthcare personnel during clinical procedures to protect the face from splashes of blood and other body fluids.
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Medical respiratory protective mask
MD Class I
For medical, surgical, dental and isolation settings, helping limit transfer of microorganisms, blood, body fluids and airborne particles.
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Medical face shield · 02
MD Class I
Provides a facial barrier for healthcare personnel during clinical procedures against splashes of blood and body fluids.
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Eye splash shield
MD Class I
Protects the eyes during examination and treatment from droplets, liquids and other particles.
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Healthcare and visitor isolation gown (export entry)
MD Class I · Export Only
Worn by healthcare personnel or visitors as a barrier when in contact with patients. This certificate is an export-only entry.
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Medical protective isolation gown
MD Class I
Provides a barrier between patients and healthcare personnel, helping limit transfer of microorganisms, body fluids and particles.
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Healthcare and visitor isolation gown
MD Class I
Worn by healthcare personnel or visitors to provide a barrier during patient contact and reduce transfer of infectious material.
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Patient turning and transfer sheet
MD Class I
For manually turning, repositioning, lifting and transferring patients. The certificate describes a single-patient-use product.
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