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EUDAMED registration 15099590686574No

ClearLLab Compensation Kit

Beckman Coulter India Private LimitedClass CEU EUDAMEDTrade name: ClearLLab Compensation Kit
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class C
CND nomenclatures code
W0103080101
Trade name
ClearLLab Compensation Kit
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
15099590686574
Basic UDI
150995906B74074UC
Version date
January 02, 2023
Manufacturer last update
September 13, 2022
Active status
No
Manufacturer
Manufacturer name
Beckman Coulter India Private Limited
Country
India
Country type
NON_EU
Address
not applicable Plot No 37/1 Hitech/Defence Aerospace IT Sector Mahadevakodigehalli village Karnataka
Email
kthyagarajan@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
Ireland
Market available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device characteristics
Human tissues
No
Animal tissues
Yes
Device description (EMDN)

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About this record

Access comprehensive regulatory information for ClearLLab Compensation Kit 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 15099590686574 and manufactured by Beckman Coulter India Private Limited in India.

This page provides complete registration details including trade name (ClearLLab Compensation Kit), 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.