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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 30505816940. The device is manufactured by ST. JUDE MEDICAL PUERTO RICO, LLC. from Puerto Rico USA, 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
OPTISURE™ Defibrillation Lead
Analysis ID: AKL 30505816940

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

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

Dec 23, 2024

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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