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Automated Glycohemoglobin Analyzer - EUDAMED Registration 06903053088916

Access comprehensive regulatory information for Automated Glycohemoglobin Analyzer 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 06903053088916 and manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. in China.

This page provides complete registration details including trade name (Automated Glycohemoglobin Analyzer), manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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
06903053088916
No
Automated Glycohemoglobin Analyzer
Trade Name: Automated Glycohemoglobin Analyzer
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Device Description (EMDN)

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0201050201
Trade Name
Automated Glycohemoglobin Analyzer
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06903053088916
Basic UDI
69449040AB3000024ZP
Version Date
January 23, 2025
Manufacturer Last Update
April 24, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
/ Mindray Building, Keji 12th Road South, High-Tech Industrial Park, Nanshan Shenzhen
Email
wangxinbing@mindray.com
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 EiffestraรŸe Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Germany
Market Available
Germany:2022-05-26~None, Netherlands:2022-05-26~None
Device Characteristics
Human Tissues
No
Animal Tissues
No