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Step 1 tubes for Upper Respiratory Pathogens 16-well - EUDAMED Registration 09343044005756

Access comprehensive regulatory information for Step 1 tubes for Upper Respiratory Pathogens 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 09343044005756 and manufactured by AusDiagnostics Pty Ltd in Australia.

This page provides complete registration details including trade name (Upper Respiratory Pathogens 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.

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EUDAMED Official Data
IVD General
09343044005756
No
Step 1 tubes for Upper Respiratory Pathogens 16-well
Trade Name: Upper Respiratory Pathogens 16-well
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Device Description (EMDN)

RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0105070503
Trade Name
Upper Respiratory Pathogens 16-well
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09343044005756
Basic UDI
B-09343044005756
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
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