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THERAPY™ Ablation Catheter - Indonesia BPOM Medical Device Registration

THERAPY™ Ablation Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30501025304. The device is manufactured by IRVINE BIOMEDICAL, INC A ST. JUDE MEDICAL COMPANY from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. NUGRA KARSERA.

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BPOM Registered
Risk Class Kelas Resiko : D
THERAPY™ Ablation Catheter
Analysis ID: AKL 30501025304

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

United States

Authorized Representative

PT. NUGRA KARSERA

AR Address

Rukan Graha Mas Pemuda, Jalan Pemuda Blok AA/ 10

Registration Date

Sep 15, 2020

Expiry Date

Dec 31, 2025

Product Type

Diagnostic Cardiology Equipment

Cardiac ablation percutaneous catheter

Non Electromedic Sterile

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