Malleable Penile Prosthesis - India CDSCO Medical Device Registration
Malleable Penile Prosthesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000117_518a8c0705d6bc07b4e7169508020cca_ccc2a728f88984407b7ed2e108daeac9. This device is marketed under the brand name Rigi 10. The license holder is Swar Enterprises, 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.
Brand Name
Rigi 10
License Holder
Swar EnterprisesDevice Class
Approving Authority
CDSCO
Product Information
Rigi10™ Hydrophilic Malleable Penile Prosthesis is intended for implantation into the corpora cavernosa of the penis in men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse.
