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W.O.M. WORLD OF MEDICINE HysteroLux™ Fluid Management System - HSA Registration DE0505574

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.

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CLASS C
DE0505574
W.O.M. WORLD OF MEDICINE HysteroLux™ Fluid Management System
HSA Registration Number: DE0505574
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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.

Device 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 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
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