Singapore HSA registration DE0504206
Olympus ESG-300 Electrosurgical Generator System
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0504206
- Registration Date
- March 10, 2020
- Change Notification Approval Date
- November 26, 2024
- Retention Due Date
- March 09, 2026
Product description
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulating tissue in open surgery, laparoscopic surgery and endoscopic surgery. For monopolar argon plasma coagulation (MAPC) of tissue, the electrosurgical generator is intended to be used with a compatible Olympus argon plasma coagulation unit to deliver ionized argon gas.
Product Owner
- Short Name
- Olympus
- Address
- Kuehnstrasse 61, 22045 Hamburg, GERMANY
Registrant
- Address
- 438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Importer
- Address
- 438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Model information
- Model Name(s)
- ESG-300 Electrosurgical Generator APU-300 Argon Plasma Coagulation Unit Single Use Plasma Coagulation Probe, Axial Argon, PA-210K Single Use Plasma Coagulation Probe, Axial Argon, PA-211U Single Use Plasma Coagulation Probe, Axial Argon, PA-212U Single Use Plasma Coagulation Probe, Axial Argon, PA-210Z Single Use Plasma Coagulation Probe, Axial Argon, PA-211Z Single Use Plasma Coagulation Probe, Lateral Argon, PA-221U Single Use Plasma Coagulation Probe, Radial Argon, PA-231U Foot switch, wired Foot switch, wireless Pressure reducer Pressure reducer Pressure reducer Pressure reducer Pressure reducer
- Model Identifier(s)
- WA90003W WA90004W WA94001A WA94002A WA94003A WA94004A WA94005A WA94006A WA94007A WA94033C WA94034W WA94041A WA94042A WA94043A WA94044A WA94045A
About this record
Access comprehensive regulatory information for Olympus ESG-300 Electrosurgical Generator System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504206 and owned by Olympus Winter & Ibe GmbH. The device was registered on March 10, 2020.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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