Vyntus® ONE - India CDSCO Medical Device Registration

Vyntus® ONE is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000638_e445399a9dbffe77bd27cb131434f8c5_6ac42771c761b28d6ba2136f62148505. This device is marketed under the brand name Vyaire™ Medical. The license holder is Genworks Health Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Vyntus® ONE

UID: IMP/MD/2023/000638_e445399a9dbffe77bd27cb131434f8c5_6ac42771c761b28d6ba2136f62148505

Brand Name

Vyaire™ Medical

License Holder

Genworks Health Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Vyntus ONE system combines pulmonary function testing (Vyaire™ Medical) with cardiopulmonary exercise testing (Vyaire™ Medical) capabilities. The Vyntus ONE system allows the determination of a subjects' pulmonary function status. It includes the measurement of the subjects' breathing flows and volume by means of an ultrasound flow sensor (Vyaire™ Medical). Depending on the configuration, the determination of the total lung volume by the N2 wash-out technique and the measurement of the lung diffusion by the DLCO technique are accomplished with the supply of test gases and the gas analyzers for 02, CO2, CH4 and CO

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Vyntus® IOS

Brand: Vyaire™ Medical

Genworks Health Private Limited

Vyntus® ONE - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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