Pure Global

Dental Burs - EUDAMED Registration 06976364230527

Access comprehensive regulatory information for Dental Burs 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 06976364230527 and manufactured by Ningbo Sinyuan Bur & Tool Co., Ltd in China.

This page provides complete registration details including trade name (Dental Burs), manufacturer information, authorized representative details, competent authority (Agencia Española de Medicamentos y Productos Sanitarios), 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
06976364230527
No
Dental Burs
Trade Name: Dental Burs
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Device Description (EMDN)

DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q010501
Trade Name
Dental Burs
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06976364230527
Basic UDI
697636423BURS1PY
Version Date
August 29, 2023
Manufacturer Last Update
March 10, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.128 Xingyong Road,Yongjiang Industry Zone, Jiangbei District Ningbo, Zhejiang
Email
zm.ruan@sinyuan.com
Authorized Representative
SRN
ES-AR-000001202
Country
Spain
Address
55 Calle de Almansa Madrid
Email
leis@riomavix.com
Regulatory Information
Competent Authority
Agencia Española de Medicamentos y Productos Sanitarios
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Spain
Market Available
Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No