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Singapore HSA registration DE0508608

Hologic Omni Hysteroscopes System

Singapore flagSingapore·CLASS B·Hologic, Inc.·Registered October 27, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration information
Registration Number
DE0508608
Registration Date
October 27, 2023
Retention Due Date
October 26, 2025
Product description
The Omni Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Product Owner
Name
Hologic, Inc.
Short Name
Hologic, Inc.
Address
250 Campus Drive, Marlborough, Massachusetts, 01752, UNITED STATES
Registrant
Name
QT INSTRUMENTS (S) PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
Name
QT INSTRUMENTS (S) PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
Model Name(s)
MyoSure Rod Lens Hysteroscope Outflow Channel Omni 30 Degree Hysteroscope Outflow Channel MyoSure XL Rod Lens Hysteroscope Outflow Channel Omni 30 Degree XL Hysteroscope Outflow Channel Omni Hysteroscope Omni 30 Degree Hysteroscope Omni Diagnostic Sheath Omni 30 Degree Diagnostic Sheath Omni 5.5mm Operative Sheath Omni 30 Degree 5.5mm Operative Sheath Omni 6.0mm Operative Sheath Omni 30 Degree 6.0mm Operative Sheath Omni Hysteroscopy Standard Set Omni Hysteroscopy Light Set
Model Identifier(s)
40-201 40-201-30 50-201XL 50-201XL-30 60-200 60-200-30 60-201 60-201-30 60-202 60-202-30 60-203 60-203-30 60-250-1 60-250-2
About this record

Access comprehensive regulatory information for Hologic Omni Hysteroscopes System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508608 and owned by Hologic, Inc.. The device was registered on October 27, 2023.

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