Generator - India CDSCO Medical Device Registration

Generator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000321_92a8f0b9d28a89b480bd1d29f46f0484_3014c8aa2778b84211cb929dc4f6f6cd. This device is marketed under the brand name Mederi RF LLC. The license holder is CJ MEDICAL INDIA PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Generator

UID: IMP/MD/2021/000321_92a8f0b9d28a89b480bd1d29f46f0484_3014c8aa2778b84211cb929dc4f6f6cd

Brand Name

Mederi RF LLC

License Holder

CJ MEDICAL INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Mederi-RF Generator is intended for general use in the electrosurgical coagulation of tissue, specifically: • The Mederi-RF Generator when used with the Stretta Disposable Catheter is intended for the treatment of gastroesophageal reflux disease (Mederi RF LLC). • The Mederi-RF Generator when used with the Secca Disposable Handpiece is intended for the treatment of bowel incontinence in patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy