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EUDAMED registration 09343044005749No

Step 2 Plates for Respiratory Viruses (16-well)

AusDiagnostics Pty LtdIVD GeneralEU EUDAMEDTrade name: Respiratory Viruses (16-well)
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD General
CND nomenclatures code
W0105070503
Trade name
Respiratory Viruses (16-well)
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
09343044005749
Basic UDI
B-09343044005749
Version date
September 19, 2024
Manufacturer last update
September 19, 2023
Active status
No
Manufacturer
Manufacturer name
AusDiagnostics Pty Ltd
Country
Australia
Country type
NON_EU
Address
290-292 Coward Street Mascot
Email
gisah.sad@ausdx.com
Authorized representative
Name
Advena Limited
SRN
MT-AR-000000234
Country
Malta
Address
Tower Street Swatar
Email
prrc@advena.mt
Regulatory information
Competent authority
Malta Medicines Authority
Applicable legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed on the market
Malta
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS

About this record

Access comprehensive regulatory information for Step 2 Plates for Respiratory Viruses (16-well) in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 09343044005749 and manufactured by AusDiagnostics Pty Ltd in Australia.

This page provides complete registration details including trade name (Respiratory Viruses (16-well)), manufacturer information, authorized representative details, competent authority (Malta Medicines Authority), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.