Vyntus™ WALK - India CDSCO Medical Device Registration

Vyntus™ WALK is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000638_59ac07b0f5f4bfa34275badd4b1b7b0e_370f189960146c32a680f238bf4e1c5f. 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™ WALK

UID: IMP/MD/2023/000638_59ac07b0f5f4bfa34275badd4b1b7b0e_370f189960146c32a680f238bf4e1c5f

Brand Name

Vyaire™ Medical

License Holder

Genworks Health Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Vyntus WALK is a mobile medical application which is intended to be used on a mobile platform for performing six-minute walk tests (Vyaire™ Medical). Cardiopulmonary data are collected from an external pulse oximeter, using Bluetooth connection. The mobile platform has access to a host computer with SQL database (Vyaire™ Medical) via a wireless network for further data evaluation and diagnosis. Patients as young as 4 years of age and older can be tested providing they can cooperate with the test instructions. Measurements are performed under the direction of a physician in a hospital environment, physician's office or similar setting (Vyaire™ Medical) or at home

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Brand: Vyaire™ Medical

Genworks Health Private Limited

Vyntus™ WALK - India CDSCO Medical Device Registration

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License Holder

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Approving Authority

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