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Dental Root Canal Instruments - EUDAMED Registration 06977854443335

Access comprehensive regulatory information for Dental Root Canal Instruments 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 06977854443335 and manufactured by Shanghai Xingyu Medical Equipment Co.,Ltd in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf 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
06977854443335
No
Dental Root Canal Instruments
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

DENTAL SURGERY INSTRUMENT KITS, SINGLE-USE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010508
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06977854443335
Basic UDI
697492240FILESMT
Version Date
October 12, 2024
Manufacturer Last Update
December 30, 2022
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
3 Floor, Building 21, No.3825 Xin Zhuan Road, Dong Jing Town, Song Jiang District Shanghai
Email
htm0086@vip.163.com
Authorized Representative
SRN
DE-AR-000005110
Country
Germany
Address
1 Kochstr Willich
Email
info.m@luxuslw.de
Telephone
+49 1715605732
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Poland
Market Available
Poland:2015-03-05~2099-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No