Singapore HSA registration DE0508857Suzhou AcuVu HTx Disposable Hysteroscope System
- Device Class
- CLASS B
- Medical Speciality Area
- Obstetrics & Gynaecology
- Registration Number
- DE0508857
- Registration Date
- January 17, 2024
- Change Notification Approval Date
- February 26, 2025
- Retention Due Date
- January 16, 2026
HTx disposable hysteroscope system is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
- Short Name
- Suzhou Acuvu Medical Technology Co., Ltd.
- Address
- B1-212, Bio-Nano Park, 218 Xinghu Street, Suzhou Industrial Park, Suzhou Area, China(Jiangsu)Pilot Free Trade Zone, 215000 Suzhou, Jiangsu, CHINA
- Address
- 50 FABER WALK, WATERFRONT @ FABER, #01-36, SINGAPORE 128994
- Address
- 50 FABER WALK, WATERFRONT @ FABER, #01-36, SINGAPORE 128994
- Model Name(s)
- HTx Procedure Pack HTx Image Processing System Portable Image Processor HTx Disposable Hysteroscope HTx Disposable Hysteroscope HTx Disposable Hysteroscope HTx Disposable Hysteroscope Dongle for PIMC software
- Model Identifier(s)
- HTx procedure pack HTx1000 HTx2000 HTx40 HTx60 HTx60s HTx60t HTxPD01
Access comprehensive regulatory information for Suzhou AcuVu HTx Disposable Hysteroscope 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 DE0508857 and owned by Suzhou Acuvu Medical Technology Co., Ltd.. The device was registered on January 17, 2024.
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.