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AVALUS Bioprothesis Model 400 - Indonesia BPOM Medical Device Registration

AVALUS Bioprothesis Model 400 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503812715. The device is manufactured by MEDTRONIC MEXICO S. DE R.L. DE CV. 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
AVALUS Bioprothesis Model 400
Analysis ID: AKL 30503812715

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, Desa/Kelurahan Kebayoran Lama Utara, Kec. Kebayoran Lama

Registration Date

Jan 04, 2025

Expiry Date

Feb 20, 2029

Product Type

Prosthetic Cardiology Equipment

Replacement heart valve.

Non Electromedic Sterile

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