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Direct Bilirubin Assay Kit (Chemical Oxidation Method) - EUDAMED Registration 06975225462046

Access comprehensive regulatory information for Direct Bilirubin Assay Kit (Chemical Oxidation Method) in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI 06975225462046 and manufactured by Da Te Bioengineering 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.

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EUDAMED Official Data
IVD General
06975225462046
No
Direct Bilirubin Assay Kit (Chemical Oxidation Method)
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

BILIRUBIN

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W01010203
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06975225462046
Basic UDI
B-06975225462046
Version Date
March 09, 2023
Manufacturer Last Update
September 23, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No. 19, Xiangshan Road, Industrial Development Park, High and New Technology, Guangzhou, Guangdong, China Guangzhou
Email
dategz@sina.com
Authorized Representative
SRN
NL-AR-000000121
Country
Netherlands
Address
Koningin Julianaplein 10, 1e Verd The Hague
Email
peter@lotusnl.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Netherlands
Market Available
Belgium:None~None, France:None~None, Germany:None~None, Italy:None~None, Netherlands:None~None, Sweden:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No