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/2020/000088_ac48dcfd5e97b379b8f9f5b978768108_d5747d677a769d008cac71755cd6dbab. This device is marketed under the brand name Portex. The license holder is Smiths Medical India Private Limited ,Gala 7A & 8A, Ground Floor, Building No. E-3, H No 508, Shree Rajalaxmi Logistics Park, Bhiwandi Nashik Road, Dhamangaon Bhiwandi, Thane - 421302, Maharashtra, India. ,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/2020/000088_ac48dcfd5e97b379b8f9f5b978768108_d5747d677a769d008cac71755cd6dbab

Brand Name

Portex

License Holder

Smiths Medical India Private Limited ,Gala 7A & 8A, Ground Floor, Building No. E-3, H No 508, Shree Rajalaxmi Logistics Park, Bhiwandi Nashik Road, Dhamangaon Bhiwandi, Thane - 421302, Maharashtra, India. ,Thane Maharashtra ,421302 ,India

Device Class

Class B

Approving Authority

CDSCO

Product Information

A range of sterile single-use tracheostomy tubes with an adjustable flange for use on patients with abnormal skin to trachea depth and/or to facilitate stoma care

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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

Class B