Tracheo-bronchial silicone stent - India CDSCO Medical Device Registration

Tracheo-bronchial silicone stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000272_414f29882cbf99532bd3ad946bd7f8ff_e4805da856c6bee86d27efd15b6cc925. This device is marketed under the brand name NOVATECH GSS. The license holder is SHREYAAS HEALTH CARE PRODUCTS 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

Tracheo-bronchial silicone stent

UID: IMP/MD/2021/000272_414f29882cbf99532bd3ad946bd7f8ff_e4805da856c6bee86d27efd15b6cc925

Brand Name

NOVATECH GSS

License Holder

SHREYAAS HEALTH CARE PRODUCTS PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

Stent for use in the trachea or bronchus. The product is used to keep the airway open. The product is for long-term use (NOVATECH GSS). Indications for Use • Tracheobronchial tumors • Tracheal stenoses with scarring • Tracheabronchial stenoses after anastomosis, resection or lung transplantation • Diameter reduction from intraluminal, extraluminal and intramural changes