Pure Global

ROTAPRO™ Rotational Atherectomy System - Indonesia BPOM Medical Device Registration

ROTAPRO™ Rotational Atherectomy System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20504127086. The device is manufactured by BOSTON SCIENTIFIC CORPORATION from United States, and is classified as Risk Class Kelas Resiko : B. 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
ROTAPRO™ Rotational Atherectomy System
Analysis ID: AKL 20504127086

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

BOSTON SCIENTIFIC INDONESIA

AR Address

Prudential Tower lantai 28 Jl. Jend. Sudirman Kav. 79

Registration Date

Nov 18, 2021

Expiry Date

Jan 26, 2026

Product Type

Surgical Cardiology Equipment

Coronary atherectomy catheter

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing