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GALLANT™ HF Implantable Cardioverter Defibrillators (ICDs) and CRT-Ds - Indonesia BPOM Medical Device Registration

GALLANT™ HF Implantable Cardioverter Defibrillators (ICDs) and CRT-Ds is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503126988. The device is manufactured by ST JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. TAWADA HEALTHCARE.

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BPOM Registered
Risk Class Kelas Resiko : D
GALLANT™ HF Implantable Cardioverter Defibrillators (ICDs) and CRT-Ds
Analysis ID: AKL 30503126988

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

United States

Authorized Representative

PT. TAWADA HEALTHCARE

AR Address

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

Registration Date

Nov 17, 2021

Expiry Date

Jun 26, 2025

Product Type

Prosthetic Cardiology Equipment

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

Non Electromedic Sterile

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