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Thoratec HeartMate II Left Ventricular Assist System - Indonesia BPOM Medical Device Registration

Thoratec HeartMate II Left Ventricular Assist System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503915576. The device is manufactured by THORATEC CORPORATION from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. TRANSMEDIC INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : D
Thoratec HeartMate II Left Ventricular Assist System
Analysis ID: AKL 30503915576

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

United States

Authorized Representative

PT. TRANSMEDIC INDONESIA

AR Address

PERKANTORAN MENARA ERA UNIT G-01, JL. SENEN RAYA NO. 135-137

Registration Date

Sep 03, 2019

Expiry Date

Dec 31, 2024

Product Type

Prosthetic Cardiology Equipment

Ventricular bypass (assist) device.

Non Radiation Electromedics

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