06974242192851

Carbide Bur

Chengdu Sani Medical Equipment Co.,Ltd.·Class IIa·EU EUDAMED·Trade name: Dental Endo MotorNo

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: 06974242192851
Basic UDI: B-06974242192851
Version date: July 12, 2024
Manufacturer last update: August 16, 2021
Active status: No

Manufacturer

Manufacturer name: Chengdu Sani Medical Equipment Co.,Ltd.
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

Name: SUNGO Europe B.V.
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: Denmark
Market available: Denmark:2021-06-30~2025-08-01, Finland:2021-06-30~2025-08-01, Greece:2021-06-30~2025-08-01, Hungary:2021-06-30~2025-08-01, Italy:2021-06-30~2025-08-01, Liechtenstein:2021-06-30~2025-08-01, Lithuania:2021-06-30~2025-08-01, Malta:2021-06-30~2025-08-01, Netherlands:2021-06-30~2025-08-01, Romania:2021-06-30~2025-08-01

Device characteristics

Human tissues: No
Animal tissues: No

Device description (EMDN)

ODONTOSTOMATOLOGY BURS, REUSABLE

About this record

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 06974242192851 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.