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FARADRIVE Steerable Sheath - Indonesia BPOM Medical Device Registration

FARADRIVE Steerable Sheath is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30504420146. The device is manufactured by CENTERPOINT SYSTEMS, LLC., UTAH from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is BOSTON SCIENTIFIC INDONESIA.

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
FARADRIVE Steerable Sheath
Analysis ID: AKL 30504420146

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

United States

Authorized Representative

BOSTON SCIENTIFIC INDONESIA

AR Address

PRUDENTIAL TOWER, LT. 28, JL. JEND. SUDIRMAN KAV. 79

Registration Date

Oct 16, 2024

Expiry Date

May 28, 2029

Product Type

Surgical Cardiology Equipment

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation

Non Electromedic Sterile

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