Singapore HSA registration DE0509600
SOPRO CO2 Gas Insufflator
Singapore·CLASS B·SOPRO·Registered July 30, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0509600
- Registration Date
- July 30, 2024
- Retention Due Date
- July 29, 2025
Product description
The device and the associated accessories are intended to create a pneumoperitoneum (distension of the abdominal cavity) by filling with CO2 (at a temperature adapted to that of the human body) at a known pressure and flow rate according to a defined instruction, under the responsibility of the surgeon during a diagnosis or laparoscopic surgery.
Product Owner
- Name
- SOPRO
- Short Name
- SOPRO
- Address
- ZAC Athelia IV, Avenue des Genevriers, 13705 La Ciotat, Cedex France, FRANCE
Registrant
- Address
- 25 INTERNATIONAL BUSINESS PARK, GERMAN CENTRE, #02-61/64, SINGAPORE 609916
Importer
- Address
- 25 INTERNATIONAL BUSINESS PARK, GERMAN CENTRE, #02-55/56, SINGAPORE 609916
Model information
- Model Name(s)
- CO2 Gas Insufflator Insufflation Tubing
- Model Identifier(s)
- 10830-003 20830-013
About this record
Access comprehensive regulatory information for SOPRO CO2 Gas Insufflator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509600 and owned by SOPRO. The device was registered on July 30, 2024.
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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