Pad Infant Phototherapy Unit - India CDSCO Medical Device Registration

Pad Infant Phototherapy Unit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000664_24b54994345a801b414a9cf995782f4a_f4be9016427e7f7e612f00ebd49d6150. This device is marketed under the brand name RAN. The license holder is Nice Neotech Medical Systems Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Tamil Nadu.

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CDSCO Registered

Class Class B

Pad Infant Phototherapy Unit

UID: MFG/MD/2023/000664_24b54994345a801b414a9cf995782f4a_f4be9016427e7f7e612f00ebd49d6150

Brand Name

RAN

License Holder

Nice Neotech Medical Systems Pvt. Ltd.

Device Class

Class B

Approving Authority

Tamil Nadu

Product Information

A device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (RAN). It consists of a fibreoptic-light source that connects through a flexible fibreoptic cable to a transparent blanket-like wrap or pad which emits the light and covers or encloses the neonate's body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. This device can be suitable for home-use