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BMS PROMISE ™- NITINOL SELF-EXPANDING PERIPHERAL STENT SYSTEM - ARCSA Registration f5ee5b29f21d1991eab7f86b9cce08b8

Access comprehensive regulatory information for BMS PROMISE ™- NITINOL SELF-EXPANDING PERIPHERAL STENT SYSTEM in the Ecuador medical device market through Pure Global AI's free database. This IV medical device is registered under ARCSA ID f5ee5b29f21d1991eab7f86b9cce08b8 and manufactured by MERIL LIFE SCIENCES PVT, LTD. The device was registered on September 24, 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.

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ARCSA Official Data
IV
f5ee5b29f21d1991eab7f86b9cce08b8
BMS PROMISE ™- NITINOL SELF-EXPANDING PERIPHERAL STENT SYSTEM
ARCSA ID: f5ee5b29f21d1991eab7f86b9cce08b8
Local name: PROMESA ™ BMS- SISTEMA DE STENT PERIFÉRICO AUTO-EXPANDIBLE DE NITINOL
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Device Classification
Risk Class
IV
Product Type
Invasive
Brand Name
MERIL LIFE SCIENCES PVT, LTD
Commercial Name
Stents, Vascular, Peripheral
Registration Information
Analysis ID
f5ee5b29f21d1991eab7f86b9cce08b8
Registration Date
September 24, 2021
Expiration Date
September 24, 2026
Product Use

IT IS DESIGNED FOR USE IN THE TREATMENT OF ARTERIOSCLEROTIC DISEASES OF PERIPHERAL ARTERIES WITH A REFERENCE VESSEL DIAMETER OF 5.00 MM TO 7.00 MM FOR THE SUPERFICIAL FEMORAL ARTERY (FAB) AND 7.00 MM TO 10.00 MM FOR THE ILIAC ARTERY IN PATIENTS ELIGIBLE FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURES AND STENTING.

Manufacturer
City
VAPI
Country
INDIA
Address
SURVEY NO. 135/2/A AND 135/2/B, 174/2 (M1-M2, MERIL PARK, FOURTH FLOOR), NEAR G.M. BILAKHIA STADIUM, MUKTANAND MARG, CHALA, VAPI, DIST. VALSAD GUJARAT
Product Owner
Name
HEALTH SPHERE LLC
Country
UNITED STATES
Authorized Representative
Address
AV DE LOS SHYRIS N9-38 AND BELGICA STREET
Phone
23800917