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BK Ultrasound Scanner System - Indonesia BPOM Medical Device Registration

BK Ultrasound Scanner System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501612716. The device is manufactured by BK MEDICAL HOLDING COMPANY INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INDOSOPHA SAKTI.

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 : B
BK Ultrasound Scanner System
Analysis ID: AKL 21501612716

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. INDOSOPHA SAKTI

AR Address

JL. MAMPANG PRAPATAN RAYA NO.1

Registration Date

Jul 05, 2024

Expiry Date

Jun 30, 2026

Product Type

Diagnostic Radiology Equipment

Ultrasonic pulsed doppler imaging system.

Non Radiation Electromedics

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