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EUDAMED registration 05700574037437No

Agilent CytoDx Software

Agilent Technologies, Inc.Class CEU EUDAMEDTrade name: Agilent CytoDx Software
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class C
CND nomenclatures code
W02079092
Trade name
Agilent CytoDx Software
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
05700574037437
Basic UDI
570057R0403P3011C040700PB
Version date
June 20, 2024
Manufacturer last update
October 15, 2021
Active status
No
Manufacturer
Manufacturer name
Agilent Technologies, Inc.
Country
United States
Country type
NON_EU
Address
5301 Stevens Creek Blvd. Santa Clara
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)

VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

About this record

Access comprehensive regulatory information for Agilent CytoDx Software in the European Union medical device market through Pure Global AI's free database. This Class C device is registered with EU EUDAMED under Primary DI 05700574037437 and manufactured by Agilent Technologies, Inc. in United States.

This page provides complete registration details including trade name (Agilent CytoDx Software), 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.