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W.O.M. Insufflator 50L for Laparoscopy FM134 - HSA Registration DE0509299

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.

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CLASS B
DE0509299
W.O.M. Insufflator 50L for Laparoscopy FM134
HSA Registration Number: DE0509299
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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.

Device 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 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