Pure Global

SOPRO CO2 Gas Insufflator - HSA Registration DE0509600

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0509600
SOPRO CO2 Gas Insufflator
HSA Registration Number: DE0509600
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 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