Pure Global

ISOFLEX Lead - Indonesia BPOM Medical Device Registration

ISOFLEX Lead is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503915392. 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : D
ISOFLEX Lead
Analysis ID: AKL 30503915392

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 5 Jl. Tentara Pelajar No. 5

Registration Date

Feb 06, 2025

Expiry Date

Apr 08, 2029

Product Type

Prosthetic Cardiology Equipment

Cardiovascular permanent pacemaker electrode.

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing