Pure Global

FOCUS & FUSION Ultrasound Diagnostic System - Indonesia BPOM Medical Device Registration

FOCUS & FUSION Ultrasound Diagnostic System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501120981. The device is manufactured by FOCUS & FUSION HEALTHCARE (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL 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
FOCUS & FUSION Ultrasound Diagnostic System
Analysis ID: AKL 21501120981

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. ANDAMAN MEDICAL INDONESIA

AR Address

Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma

Registration Date

Feb 22, 2021

Expiry Date

Sep 27, 2025

Product Type

Diagnostic Radiology Equipment

Ultrasonic pulsed echo imaging system.

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing