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EUDAMED registration 06972337852222No

i-Check Blood Gas Analyzer,Handheld

B&E BIO-TECHNOLOGY CO., LTD.Class AEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W02029099
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06972337852222
Basic UDI
697233785i-CheckA012MJ
Version date
December 24, 2024
Manufacturer last update
April 25, 2022
Active status
No
Manufacturer
Manufacturer name
B&E BIO-TECHNOLOGY CO., LTD.
Country
China
Country type
NON_EU
Address
No.11 Jieaisi Road,Laishan District,Yantai City Shandong Province
Email
Xinlei.liu@besic.cn
Authorized representative
Name
SUNGO Europe B.V.
SRN
NL-AR-000000247
Country
Netherlands
Address
Fascinatio Boulevard 522, Unit 1.7 Capelle aan den IJssel
Email
ec.rep@sungoglobal.com
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Austria
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, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER

About this record

Access comprehensive regulatory information for i-Check Blood Gas Analyzer,Handheld 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 06972337852222 and manufactured by B&E BIO-TECHNOLOGY CO., LTD. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.