Eu Mdd Eu Md Class 2b On The Market 🇰🇷 South Korea

Ultrasonic Surgical Series

SAESHIN PRECISION CO.,LTD. · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1

Basic Information

Primary DI
08809260470101
Basic UDI-DI Code
B-08809260470101
Reference
SUS10
Device Types
Sterilization
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

SUS10 combines the function of piezo surgery by using ultrasonic mechanical vibration and the function of dental implant motor surgery into one device. SUS10 consists of Control Box (main unit), Motor, Handpiece for implant surgery, Ultrasonic Handpiece for piezo surgery, Foot Controller, Ultrasonic tips and accessories. When the AC power is connected to the control box by the power cord, the control box has a program for ultrasonic surgery mode which be able to select options such as power (output intensity) and boost (vibration frequency), and for implant motor surgery mode which be able to select options such as speed, torque and gear ratio, and includes the memory function for input and output settings.

CND Nomenclature Codes

Code Description
L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER

Certificates

Type Number
MDD Annex II (excluding section 4) KR19/81826253

Available In Countries

🇧🇪 Belgium 🇩🇪 Germany

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