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FORTIFY Assura DR - Indonesia BPOM Medical Device Registration

FORTIFY Assura DR is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505918788. The device is manufactured by ABBOTT MEDICAL from Puerto Rico USA, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.

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
FORTIFY Assura DR
Analysis ID: AKL 30505918788

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

ABBOTT MEDICAL

Country of Origin

Puerto Rico USA

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

Rukan Permata Senayan Blok A18-19 Lantai 1-2 Jl. Tentara Pelajar No. 5

Registration Date

Feb 22, 2023

Expiry Date

Oct 11, 2026

Product Type

Prosthetic Cardiology Equipment

Implantable Cardioverter Defibrillator (Non-Crt)

Non Radiation Electromedics

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