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CDSCO UID IMP/MD/2020/000103_dbab9485da3cc693ce726a23868eb90a_c9318487339fda778bfceee66b4f9443

Orator- Tracheostomy speaking valve

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·Device Class Class B·India CDSCO·Brand: Portex
Registration details
UID
IMP/MD/2020/000103_dbab9485da3cc693ce726a23868eb90a_c9318487339fda778bfceee66b4f9443
Device class
Class B
Brand name
Portex
License holder
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
Approving authority
CDSCO
Product information
A one way speaking valve intended for single patient use which can be used with fenestrated, cuffed or uncuffed tracheostomy tubes
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About this record

Orator- Tracheostomy speaking valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000103_dbab9485da3cc693ce726a23868eb90a_c9318487339fda778bfceee66b4f9443. This device is marketed under the brand name Portex. 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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