Singapore HSA registration DE0505574
W.O.M. WORLD OF MEDICINE HysteroLux™ Fluid Management System
Singapore·CLASS C·W.O.M. World of Medicine GmbH·Registered March 18, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0505574
- Registration Date
- March 18, 2021
- Change Notification Approval Date
- October 18, 2022
- Retention Due Date
- March 17, 2026
Product description
The HysteroLux™ Fluid Management System is a combined suction and irrigation control unit for use in hysteroscopic interventions. The HysteroLux™ Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the distension fluid flowing into and out of the uterus.
Product Owner
- Short Name
- W.O.M. World of Medicine GmbH
- Address
- Salzufer 8, 10587 Berlin, GERMANY
Registrant
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
- Name
- COVIDIEN PRIVATE LIMITED MEDTRONIC INTERNATIONAL TRADING PTE. LTD. MEDTRONIC INTERNATIONAL, LTD.
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
- Model Name(s)
- HysteroLux™ Fluid Management System Control Unit HysteroLux™ Fluid Management System Scale HysteroLux™ Hysteroscopic Procedure Kit HysteroLux™ Hysteroscopic Vacuum Tube Set HysteroLux™ Hysteroscopic Inflow Tube Set Vacuum regulator Vacuum Regulator, Push to Set, Continuous 2 Mode, 760mmHg Analog
- Model Identifier(s)
- 72205000 72205001 72205015 72205027 72205028 72205029 72205041
About this record
Access comprehensive regulatory information for W.O.M. WORLD OF MEDICINE HysteroLux™ Fluid Management System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505574 and owned by W.O.M. World of Medicine GmbH. The device was registered on March 18, 2021.
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 C