Neonatal Phototherapy Unit - India CDSCO Medical Device Registration

Neonatal Phototherapy Unit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000508_61d8ae399bedc2c22d41e3338c799345_dbc11771c40f1cfc3c51017625262831. This device is marketed under the brand name MAC 2000. The license holder is Wipro GE Healthcare Private Limited, and it is classified as Device Class Class B. The approving authority is Karnataka.

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CDSCO Registered

Class Class B

Neonatal Phototherapy Unit

UID: MFG/MD/2023/000508_61d8ae399bedc2c22d41e3338c799345_dbc11771c40f1cfc3c51017625262831

Brand Name

MAC 2000

License Holder

Wipro GE Healthcare Private Limited

Device Class

Class B

Approving Authority

Karnataka

Product Information

The Lullaby LED Phototherapy System is used for the treatment of indirect hyperbilirubinemia in term and pre-term infants, in a hospital environment – NICUs, PICUs and Well-baby Nurseries - administered by trained, professional medical staff, on the order of a licensed medical practitioner. The Lullaby LED PT system is intended for use under the direct supervision of a licensed healthcare practitioner. The Lullaby LED PT system device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities