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Singapore HSA registration DE0501949

W.O.M. WORLD OF MEDICINE FM134 Insufflator for Laparoscopy

Singapore flagSingapore·CLASS B·W.O.M. World of Medicine GmbH·Registered July 26, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0501949
Registration Date
July 26, 2018
Change Notification Approval Date
April 11, 2023
Retention Due Date
July 25, 2025
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 Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.
Product Owner
Name
W.O.M. World of Medicine GmbH
Short Name
W.O.M. World of Medicine GmbH
Address
Salzufer 8, 10587 Berlin, GERMANY
Registrant
Name
COVIDIEN PRIVATE LIMITED
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Name
COVIDIEN PRIVATE LIMITED
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
Model Name(s)
Insufflator 50L Heating tube set for insufflation, single-use Heating tube set for insufflation, reusable Tube set for insufflation, single-use Tube set for insufflation, reusable High pressure hose 1.5m PIN/US High pressure hose DIN/US High pressure hose 1.5m ISO/US Adaptor DISS for universal gas connection Gas connector CO2 angled standard Hose for CO2 central gas DIN-US, 3m Hose for CO2 central gas DIN-US, 5m Hose for CO2 central gas NF-US, 3m Hose for CO2 central gas NF-US, 5m Hose for CO2 central gas UNI-US, 3m Hose for CO2 central gas UNI-US, 5m Hose for CO2 central gas AGA-US, 3m Hose for CO2 central gas AGA-US, 5m Hose for CO2 central gas DISS:DISS, 3m
Model Identifier(s)
FM134 Z0260 Z0280 Z0293 Z0452-01 Z0499-01 Z5044-01 Z5045-01 Z5075-01 Z5077-01 Z5100-01 Z5101-01 Z5102-01 Z5103-01 Z5104-01 Z5105-01 Z5106-01 Z5107-01 Z5108-01
About this record

Access comprehensive regulatory information for W.O.M. WORLD OF MEDICINE FM134 Insufflator for Laparoscopy in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501949 and owned by W.O.M. World of Medicine GmbH. The device was registered on July 26, 2018.

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