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Carbide Bur - EUDAMED Registration 06974242192837

Access comprehensive regulatory information for Carbide Bur 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 06974242192837 and manufactured by Chengdu Sani Medical Equipment Co.,Ltd. in China.

This page provides complete registration details including trade name (Dental Endo Motor), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
06974242192837
No
Carbide Bur
Trade Name: Dental Endo Motor
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Device Description (EMDN)

ODONTOSTOMATOLOGY BURS, REUSABLE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
L159007
Trade Name
Dental Endo Motor
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
06974242192837
Basic UDI
B-06974242192837
Version Date
July 12, 2024
Manufacturer Last Update
August 16, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
3-408,Tengfei Fourth Road Southwest Airport Economic Development Zone Chengdu,Sichuan Province
Email
534699534@qq.com
Authorized Representative
SRN
NL-AR-000000247
Country
Netherlands
Address
Fascinatio Boulevard 522, Unit 1.7 Capelle aan den IJssel
Email
ec.rep@sungoglobal.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Greece
Market Available
Austria:2022-12-13~2025-08-01, Bulgaria:2022-12-13~2025-08-01, Cyprus:2022-12-13~2025-08-01, Finland:2022-12-13~2025-08-01, Greece:2022-12-13~2025-08-01, Ireland:2022-12-13~2025-08-01, Norway:2022-12-13~2025-08-01, Slovakia:2022-12-13~2025-08-01, Spain:2022-12-13~2025-08-01
Device Characteristics
Human Tissues
No
Animal Tissues
No