Wuxi Hisky Medical Technologies Co.,Ltd.

Address:Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park, 214135 Wuxi,,Wuxi 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

Transducer, Ultrasonic, Diagnostic (ITX) (3) System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1)

Premarket Exempt

Clear

Shear Wave Quantificational Ultrasound Diagnostic System - 06971679945005 Catalog Number :

Device Class : 2

Duns Number: 544348534

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

Imaging Probe - 06971679947016 Catalog Number :

Device Class : 2

Duns Number: 544348534

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Fibrosis Scanning Probe - 06971679947023 Catalog Number :

Device Class : 2

Duns Number: 544348534

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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