Singapore HSA registration DE0503030
W.O.M. Insufflator 50L
Singapore·CLASS B·W.O.M. World of Medicine GmbH·Registered April 24, 2019Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0503030
- Registration Date
- April 24, 2019
- Change Notification Approval Date
- February 14, 2023
- Retention Due Date
- April 23, 2026
Product description
The device Insufflator 50L FM134 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
- Short Name
- W.O.M. World of Medicine GmbH
- Address
- Salzufer 8, 10587 Berlin, GERMANY
Registrant
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
- Model Name(s)
- Insufflator 50L Z0260 Z0280 Z0293 Z0452-01 Z0499-01 Z0531-00 Z5044-01 Z5045-01 Z5074-01 Z5075-01 Z5077-01 Z5078-01 Z5080-01 Z5100-01 Z5101-01 Z5102-01 Z5103-01 Z5104-01 Z5105-01 Z5106-01 Z5107-01 Z5108-01
- Model Identifier(s)
- FM-134 Z0260 Z0280 Z0293 Z0452-01 Z0499-01 Z0531-00 Z5044-01 Z5045-01 Z5074-01 Z5075-01 Z5077-01 Z5078-01 Z5080-01 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. Insufflator 50L in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503030 and owned by W.O.M. World of Medicine GmbH. The device was registered on April 24, 2019.
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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