Singapore HSA registration DE0509299
W.O.M. Insufflator 50L for Laparoscopy FM134
Singapore·CLASS B·W.O.M. World of Medicine GmbH·Registered May 20, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0509299
- Registration Date
- May 20, 2024
- Retention Due Date
- May 19, 2026
Product description
The device Insufflator 50L is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.
Product Owner
- Short Name
- W.O.M. World of Medicine GmbH
- Address
- Salzufer 8, 10587 Berlin, Deutschland, 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)
- Insufflator 50L FM134 Heating tube set for insufflation, single-use Heating tube set for insufflation, reusable Tube set for insufflation, single-use Tube set for insufflation, reusable Hose for CO2 gas bottle PIN:US, 1.5m Switch valve for insufflators Hose for CO2 gas bottle DIN:US, 1.5m Hose for CO2 gas bottle ISO:US, 1.5m Sinter filter for universal gas connection angled NIST connector for universal connection DISS Adaptor for univ. gas connection CO2 gas connecter, angled Hose for CO2 gas bottle CGA:US, 1.5 m Hose for CO2 central gas DIN:US, 5 m Hose for CO2 central gas DISS:DISS, 3 m
- Model Identifier(s)
- 2205471 Z0260 Z0280 Z0293 Z0452-01 Z0499-01 Z0531-00 Z5044-01 Z5045-01 Z5072-01 Z5074-01 Z5075-01 Z5077-01 Z5080-01 Z5101-01 Z5108-01
About this record
Access comprehensive regulatory information for W.O.M. Insufflator 50L for Laparoscopy FM134 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509299 and owned by W.O.M. World of Medicine GmbH. The device was registered on May 20, 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 DatabasePowered by Pure Global AIHSA Official DataCLASS B