Pure Global

FOCUS Total Bilirubin (TBil)/VOX) - Indonesia BPOM Medical Device Registration

FOCUS Total Bilirubin (TBil)/VOX) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221028. The device is manufactured by SHENZEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FOCUS DIAGNOSTIC 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 Total Bilirubin (TBil)/VOX)

FOKUS Total Bilirubin (TBil)/VOX)

Analysis ID: AKL 20101221028

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. FOCUS DIAGNOSTIC INDONESIA

AR Address

18 Office Park, Tower A, Jl. TB Simatupang No.18 MZ Floor, Unit D1-A/89, Kelurahan Kebagusan

Registration Date

Jul 15, 2022

Expiry Date

Apr 14, 2024

Product Type

Clinical Chemistry Test System

Bilirubin (total or direct) test system (kit & cair)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing