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Tracheostomy Tubes - India CDSCO Medical Device Registration

Tracheostomy Tubes is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000321_ac48dcfd5e97b379b8f9f5b978768108_baf18b5e40de5643ee9569b6bcce5e80. This device is marketed under the brand name Bivona. The license holder is SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Tracheostomy Tubes
UID: IMP/MD/2020/000321_ac48dcfd5e97b379b8f9f5b978768108_baf18b5e40de5643ee9569b6bcce5e80

Brand Name

Bivona

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Bivonaยฎ Tracheostomy Tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times

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