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CDSCO UID IMP/MD/2020/000367_8213675e197c451cf1ab9f65d24cdbfe_f2d9b1352dfffe63a7b7f7846233c874

Needles

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 C·India CDSCO·Brand: Single Lumen Portal Systs
Registration details
UID
IMP/MD/2020/000367_8213675e197c451cf1ab9f65d24cdbfe_f2d9b1352dfffe63a7b7f7846233c874
Device class
Class C
Brand name
Single Lumen Portal Systs
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
Approving authority
CDSCO
Product information
This product is indicated for administration into or withdrawal of fluids from the implanted ports. It is designed to help against exposure to blood borne pathogens caused by accidental needle stick injuries. When used with power injectable implantable venous access ports, this product is indicated for power injecting contrast media
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Other products with the same name or brand
Needles
Brand: Argon
M/s. Terumo India Pvt. Ltd.
Class B
Ports
Brand: Single Lumen Portal Systs
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
Class C
Ports
Brand: Single Lumen Portal Systs
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
Class C
Ports
Brand: Single Lumen Portal Systs
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
Class C
Ports
Brand: Single Lumen Portal Systs
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
Class C
Ports
Brand: Single Lumen Portal Systs
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
Class C
Needles
Brand: Single Lumen Portal Systs
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
Class C
Needles
Brand: Single Lumen Portal Systs
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
Class C
VA Introducers
Brand: Single Lumen Portal Systs
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
Class C
Needles
Brand: Angiographic Tray
M/s Merit Medical Systems India Pvt. Ltd.,
Class B
Other products from 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
Products from the same license holder (10 products)
Ports
Brand: Single Lumen Portal Systs
Class C
Ports
Brand: Single Lumen Portal Systs
Class C
Ports
Brand: Single Lumen Portal Systs
Class C
Ports
Brand: Single Lumen Portal Systs
Class C
Ports
Brand: Single Lumen Portal Systs
Class C
Needles
Brand: Single Lumen Portal Systs
Class C
Needles
Brand: Single Lumen Portal Systs
Class C
VA Introducers
Brand: Single Lumen Portal Systs
Class C
Combined Spinal Epidural Minipack
Brand: Rapid Portex, Portex
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Brand: Bivona
Class B
About this record

Needles is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000367_8213675e197c451cf1ab9f65d24cdbfe_f2d9b1352dfffe63a7b7f7846233c874. This device is marketed under the brand name Single Lumen Portal Systs. 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 C. The approving authority is CDSCO.

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