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EUDAMED registration 09343044004780No

Nucleic acid Extraction/isolation Kit IVD

AusDiagnostics Pty LtdClass AEU EUDAMEDTrade name: RIDA®PrepX Stool Kit
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W0105900101
Trade name
RIDA®PrepX Stool Kit
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
09343044004780
Basic UDI
93430440W010590010157
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
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Malta
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

About this record

Access comprehensive regulatory information for Nucleic acid Extraction/isolation Kit IVD in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 09343044004780 and manufactured by AusDiagnostics Pty Ltd in Australia.

This page provides complete registration details including trade name (RIDA®PrepX Stool Kit), 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.