MC-Series - EUDAMED Registration 06976374330798
Access comprehensive regulatory information for MC-Series 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 06976374330798 and manufactured by Zenith Lab (Jiangsu) 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
Class A
06976374330798
No
MC-Series
EU EUDAMED Registered Medical Device
Device Description (EMDN)
CENTRIFUGES
Device Classification
Risk Class
Class A
CND Nomenclatures Code
W02069003
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06976374330798
Basic UDI
697637433MC-SeriesES
Version Date
August 01, 2024
Manufacturer Last Update
July 28, 2022
Active Status
No
Manufacturer
Manufacturer Name
Zenith Lab (Jiangsu) Co.,LtdCountry
China
Country Type
NON_EU
Address
NO.12 NO.12,Hongshan Road,Jincheng industrial area,Jintan district Changzhou
Email
service@labzj.com
Authorized Representative
SRN
NL-AR-000000444
Country
Netherlands
Address
Treubstraat 1 Rijswijk
Email
ar@umedwings.eu
Telephone
+31 (0) 642758955
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
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No