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MEDTRONIC EVOLUT Pro Plus System - Indonesia BPOM Medical Device Registration

MEDTRONIC EVOLUT Pro Plus System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503220136. The device is manufactured by MEDTRONIC MEXICO S. DE R.L. DE C.V. from Mexico, 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
MEDTRONIC EVOLUT Pro Plus System
Analysis ID: AKL 30503220136

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Mexico

Authorized Representative

PT. MEDTRONIC INDONESIA

AR Address

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

Registration Date

Dec 12, 2022

Expiry Date

Jan 13, 2026

Product Type

Prosthetic Cardiology Equipment

Prosthesis Percutaneously Delivered Aortic Valve

Non Electromedic Sterile

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