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HSA · registration DE0508857

Suzhou AcuVu HTx Disposable Hysteroscope System

SingaporeObstetrics & GynaecologyClass BSuzhou Acuvu Medical Technology Co., Ltd.
Verified
Official record identity
Registration number
DE0508857
Model name
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
HTx procedure pack; HTx1000; HTx2000; HTx40; HTx60; HTx60s; HTx60t; HTxPD01
Registration date
January 17, 2024
Source update date
May 15, 2026
Classification
Risk class
Class B
Official value: CLASS B
Published category
Obstetrics & Gynaecology
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Published parties
Product owner
Suzhou Acuvu Medical Technology Co., Ltd.
Registrant / registration holder
VENCARE PTE. LTD.
Official description

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.

Additional source fields
Product owner address
B1-212, Bio-Nano Park, 218 Xinghu Street, Suzhou Industrial Park, Suzhou Area, China(Jiangsu)Pilot Free Trade Zone, 215000 Suzhou, Jiangsu, China
Registrant address
50 FABER WALK, #01-36, WATERFRONT @ FABER, Singapore 128994
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.