bf7ecfecbaec15cb0abc6c5dce47d93d

Monofilament Polydioxanone

UNISUR LIFECARE PVT LTD·IV·Ecuador ARCSA·Registered December 27, 2021

Device classification

Risk class: IV
Product type: Invasive
Brand name: FORTUNE MEDICAL
Commercial name: Sutures, synthetic, absorbable
Sterilization method: ETHYLENE OXIDE

Registration information

Analysis ID: bf7ecfecbaec15cb0abc6c5dce47d93d
Registration date: December 27, 2021
Expiration date: December 27, 2026
Creation date: December 28, 2021

Manufacturer

Name: UNISUR LIFECARE PVT LTD
City: KARNATAKA
Country: INDIA
Address: NO. 15/1,2,3 ANDRAHALL MAIN ROAD ACHARYA INDUSTRIA COMPLEX, VISHWANEEDAM, POST 560 091 BANGALORE, KARNATAKA , INDIA

Product owner

Name: UNISUR LIFECARE PVT LTD
Country: INDIA

Authorized representative

Name: SUMINISTROS Y DISTRIBUCIONES IVAN QUINTANILLA CIA. LTDA.
Address: CALLE ARZ. ANTONIO MACHADO 1-81 Y ARZ SERRANO
Phone: 74110904

Product use

POLYDIOXANONE MONOFILAMENT SUTURES ARE INDICATED FOR USE IN SOFT TISSUE APPROXIMATION IN GENERAL, INCLUDING USE IN PEDIATRIC CARDIOVASCULAR TISSUE, MICROSURGERY AND OPHTHALMIC SURGERY.

About this record

Access comprehensive regulatory information for Monofilament Polydioxanone in the Ecuador medical device market through Pure Global AI's free database. This IV medical device is registered under ARCSA ID bf7ecfecbaec15cb0abc6c5dce47d93d and manufactured by UNISUR LIFECARE PVT LTD. The device was registered on December 27, 2021.

This page provides complete registration details including product type (Invasive), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.