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EUDAMED registration 05700574036843No

AriaDx Real-Time PCR Instrument

Agilent Technologies Singapore (International) Pte LtdClass AEU EUDAMEDTrade name: AriaDx Real-Time PCR Instrument
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W02050116
Trade name
AriaDx Real-Time PCR Instrument
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
05700574036843
Basic UDI
570057R0802P3011A040400SD
Version date
June 25, 2024
Manufacturer last update
October 15, 2021
Active status
No
Manufacturer
Manufacturer name
Agilent Technologies Singapore (International) Pte Ltd
Country
Singapore
Country type
NON_EU
Address
1 Yishun Avenue 7 Singapore
Email
info.dk@agilent.com
Authorized representative
Name
Agilent Technologies Denmark ApS
SRN
DK-AR-000001443
Country
Denmark
Address
42 Produktionsvej Glostrup
Email
info.dk@agilent.com
Telephone
+45 44 85 95 00
Regulatory information
Competent authority
Danish Medicines Agency, Pharmacovigilance & Medical Devices
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Denmark
Market available
Denmark:2022-05-16~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

About this record

Access comprehensive regulatory information for AriaDx Real-Time PCR Instrument 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 05700574036843 and manufactured by Agilent Technologies Singapore (International) Pte Ltd in Singapore.

This page provides complete registration details including trade name (AriaDx Real-Time PCR Instrument), manufacturer information, authorized representative details, competent authority (Danish Medicines Agency, Pharmacovigilance & Medical Devices), 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.