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OPTISURE Defibrillation Lead - Indonesia BPOM Medical Device Registration

OPTISURE Defibrillation Lead is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505021699. The device is manufactured by ST. JUDE MEDICAL OPERATIONS (M) SDN. BHD. from Malaysia, 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
OPTISURE Defibrillation Lead
Analysis ID: AKL 30505021699

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Malaysia

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

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

Registration Date

Jan 04, 2025

Expiry Date

Sep 16, 2029

Product Type

Prosthetic Cardiology Equipment

Automatic Implantable Cardioverter Defibrillator With Cardiac Resynchronization (Crt-D)

Non Radiation Electromedics

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