Pure Global

Needles - India CDSCO Medical Device Registration

Needles is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000367_8213675e197c451cf1ab9f65d24cdbfe_976b218222f46964b6749d779c0f29c8. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class C
Needles
UID: IMP/MD/2020/000367_8213675e197c451cf1ab9f65d24cdbfe_976b218222f46964b6749d779c0f29c8

Brand Name

Single Lumen Portal Systs

Device Class

Class C

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

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Similar Products (10)
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