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EUDAMED registration 06974501890016No

NovoCyte Advanteon Dx Flow Cytometer

Agilent Biosciences (Hangzhou) Co., Ltd.Class AEU EUDAMEDTrade name: NovoCyte Advanteon Dx Flow Cytometer
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W02020499
Trade name
NovoCyte Advanteon Dx Flow Cytometer
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06974501890016
Basic UDI
69745018900A000301UM
Version date
August 26, 2022
Manufacturer last update
September 14, 2021
Active status
No
Manufacturer
Manufacturer name
Agilent Biosciences (Hangzhou) Co., Ltd.
Country
China
Country type
NON_EU
Address
No. 208 Zhenzhong Road Hangzhou
Email
tom.chen@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
The Medicines and Healthcare Products Regulatory Agency
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Denmark
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

FLOW CYTOMETRY INSTRUMENTS - OTHER

About this record

Access comprehensive regulatory information for NovoCyte Advanteon Dx Flow Cytometer 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 06974501890016 and manufactured by Agilent Biosciences (Hangzhou) Co., Ltd. in China.

This page provides complete registration details including trade name (NovoCyte Advanteon Dx Flow Cytometer), manufacturer information, authorized representative details, competent authority (The Medicines and Healthcare Products Regulatory Agency), 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.