Suzhou AcuVu medical technology Co., Ltd.

Address:B1-212, Bio-Nano Park, 218 Xinghu St. Suzhou Industrial Park,Suzhou Jiangsu,CN

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Hysteroscope (And Accessories) (HIH) (3)

Premarket Exempt

Clear

HTx Image Processing System - 06974880990017 Catalog Number :

Device Description : This is the control unit for the scopes. It stores images and videos on its hard This is the control unit for the scopes. It stores images and videos on its hard drive. It allows users to modify settings such as white balance and zoom.

Device Class : 2

Duns Number: 705464292

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

HTx Disposable Hysteroscope - 06974880990024 Catalog Number :

Device Description : Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine lesions. The outer diameter of the scope is 6.2 mm.

Device Class : 2

Duns Number: 705464292

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

HTx Disposable Hysteroscope - 06974880990031 Catalog Number :

Device Description : Disposable hysteroscope with a working channel suitable for 5Fr tools to cut and Disposable hysteroscope with a working channel suitable for 5Fr tools to cut and remove uterine lesions and take a biopsy. The outer diameter of the scope is 4.5 mm.

Device Class :

Duns Number: 705464292

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

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