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195 device results listed.

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Respiratory Pathogens 16-well

Step 1 tubes for Respiratory Pathogens 16-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044004186
Basic UDI-DI: B-09343044004186
Reference: 20620S
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogens 16-well

Step 2 Plates for Respiratory Pathogens 16-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044004179
Basic UDI-DI: B-09343044004179
Reference: 20620P
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginitis and vaginosis 12-well

Step 1 tubes for Vaginitis and vaginosis 12-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003905
Basic UDI-DI: B-09343044003905
Reference: 87124S
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginitis and vaginosis 12-well

Step 2 Plates for Vaginitis and vaginosis 12-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003899
Basic UDI-DI: B-09343044003899
Reference: 87124P
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Synthetic Positive Controls for HPV

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003837
Basic UDI-DI: B-09343044003837
Reference: 91191
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Step 1 tubes for Respiratory Pathogens 24-well

Respiratory Pathogens 24-well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003615
Basic UDI-DI: B-09343044003615
Reference: 80617S
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Step 2 Plates for Respiratory Pathogens 24-well

Respiratory Pathogens 24-well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003608
Basic UDI-DI: B-09343044003608
Reference: 80617P
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Synthetic Positive Controls for Haemochromatosis

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003547
Basic UDI-DI: B-09343044003547
Reference: 91171
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogens 12-well

80618P

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003509
Basic UDI-DI: B-09343044003509
Reference: 80618P
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogens 12-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003493
Basic UDI-DI: B-09343044003493
Reference: 80618S
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dermatophytes and other Fungi 12-well

Step 1 tubes for Dermatophytes and other Fungi 12-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003349
Basic UDI-DI: B-09343044003349
Reference: 84115S
EMDN: W0104030404
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dermatophytes and other Fungi 12-well

Step 2 Plates for Dermatophytes and other Fungi 12-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044003332
Basic UDI-DI: B-09343044003332
Reference: 84115P
EMDN: W0104030404
EMDN description: IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI / NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

Step 1 tubes for Urinogenital and Resistance 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002861
Basic UDI-DI: B-09343044002861
Reference: 27123S
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Step 2 Plates for Urinogenital and Resistance 12 well

Multiple sexually transmitted pathogen (Annex II) nucleic acid IVD, reagent

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002854
Basic UDI-DI: B-09343044002854
Reference: 27123P
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

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

Step 1 tubes for SARS-CoV-2, Influenza and RSV 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002762
Basic UDI-DI: B-09343044002762
Reference: 80081S
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

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

Step 2 Plates for SARS-CoV-2, Influenza and RSV 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002755
Basic UDI-DI: B-09343044002755
Reference: 80081P
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

09343044002724

Step 1 tubes for Viral Panel 12-well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002724
Basic UDI-DI: B-09343044002724
Reference: 27095S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

09343044002717

Step 2 Plates for Viral Panel 12-well

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002717
Basic UDI-DI: B-09343044002717
Reference: 27095P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Staphylococcus typing 8-well

Step 1 tubes for Staphylococcus typing 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002700
Basic UDI-DI: B-09343044002700
Reference: 21341S
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Staphylococcus typing 8-well

Step 2 Plates for Staphylococcus typing 8-well

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002694
Basic UDI-DI: B-09343044002694
Reference: 21341P
EMDN: W0105011203
EMDN description: SAPHYLOCOCCAL DETECTION BY NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 10.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details