Pure Global AI
EUDAMED registration 15099590748616No

Flow cytometer

Beckman Coulter Biotechnology Co., Ltd.Class AEU EUDAMEDTrade name: Beckman Coulter
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W0202040180
Trade name
Beckman Coulter
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
15099590748616
Basic UDI
150995907DxFLEXVE
Version date
May 17, 2022
Manufacturer last update
August 18, 2021
Active status
No
Manufacturer
Manufacturer name
Beckman Coulter Biotechnology Co., Ltd.
Country
China
Country type
NON_EU
Address
Units 101,201,301,Building 4. No.218 Sangtian Street Suzhou
Email
BECFA@beckman.com
Authorized representative
Name
Beckman Coulter Ireland Inc.
SRN
IE-AR-000000886
Country
Ireland
Address
Lismeehan Clare
Email
ra.clare@beckman.com
Telephone
+353 65 6831100
Regulatory information
Competent authority
Health Products Regulatory Authority, Medical Devices Department
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Austria
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

CYTOFLOWMETERS - HARDWARE ACCESSORIES

About this record

Access comprehensive regulatory information for 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 15099590748616 and manufactured by Beckman Coulter Biotechnology Co., Ltd. in China.

This page provides complete registration details including trade name (Beckman Coulter), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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.