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EVOLUT™ PRO + Delivery Catheter System - Indonesia BPOM Medical Device Registration

EVOLUT™ PRO + Delivery Catheter System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505220132. The device is manufactured by MEDTRONIC IRELAND from Ireland, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. MEDTRONIC INDONESIA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : D
EVOLUT™ PRO + Delivery Catheter System
Analysis ID: AKL 30505220132

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

MEDTRONIC IRELAND

Country of Origin

Ireland

Authorized Representative

PT. MEDTRONIC INDONESIA

AR Address

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda

Registration Date

Nov 30, 2022

Expiry Date

Jan 13, 2026

Product Type

Therapeutic Cardiology Equipment

Percutaneous catheter for coronary use

Non Electromedic Sterile

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