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EUDAMED registration 06970293028460No

HEMATOLOGY ANALYSIS STANING SOLUTION

Zhejiang xinke Medical Technology Co., Ltd.Class AEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W0599
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06970293028460
Basic UDI
697029302dye00177
Version date
August 01, 2024
Manufacturer last update
December 30, 2022
Active status
No
Manufacturer
Manufacturer name
Zhejiang xinke Medical Technology Co., Ltd.
Country
China
Country type
NON_EU
Address
No.133 ， Lengshui Road ， Jinpan Development Zone Jinhua City,Zhejiang Province
Email
xinkebio@188.com
Authorized representative
Name
Sungo Cert GmbH
SRN
DE-AR-000010869
Country
Germany
Address
47 Harffstr. Düsseldorf
Email
de.rep@sungoglobal.com
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market
Belgium
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

IVD GENERAL USE CONSUMABLE DEVICES - OTHER

About this record

Access comprehensive regulatory information for HEMATOLOGY ANALYSIS STANING SOLUTION 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 06970293028460 and manufactured by Zhejiang xinke Medical Technology Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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.