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Puncture Needle - EUDAMED Registration 06938695510815

Access comprehensive regulatory information for Puncture Needle in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06938695510815 and manufactured by Shanghai Kinetic Medical 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.

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EUDAMED Official Data
Class IIa
06938695510815
No
Puncture Needle
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
P099002
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06938695510815
Basic UDI
69386955KPLC
Version Date
March 10, 2025
Manufacturer Last Update
February 23, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
2F, No. 23 Building, 528 Ruiqing Rd., East Zhangjiang High-Tech Park Shanghai
Email
kinetic@shkmc.com.cn
Authorized Representative
SRN
DE-AR-000005129
Country
Germany
Address
56 Brehmstr Düsseldorf
Email
med@eulinx.eu
Telephone
+4921131054698
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Device Characteristics
Human Tissues
No
Animal Tissues
No