HemoSmart GOLD Hemoglobin Control Solution - Indonesia BPOM Medical Device Registration
HemoSmart GOLD Hemoglobin Control Solution is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205420203. The device is manufactured by APEX BIOTECHNOLOGY CORP. from Taiwan (China), and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ISOTEKINDO INTERTAMA.
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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
APEX BIOTECHNOLOGY CORP.Country of Origin
Taiwan (China)
Authorized Representative
ISOTEKINDO INTERTAMAAR Address
Jl. Raya Kebayoran Lama No. 309 C RW 01
Registration Date
Sep 27, 2024
Expiry Date
Jan 26, 2029
Product Type
Automatic and Semi-Automatic Hematology Equipment
Automated hemoglobin system (for reagent & control)
Invitro Diagnostics
UASURE II Blood Uric Acid Test Strips
MULTISURE GK Blood Ketone Test Strip
GlucoSure Autocode Blood Glucose Test Strip
UASURE II Uric Acid Control Solution
Eclipse PLUS Microalbumin Reagent Kit
Eclipse PLUS ACR Reagent Kit
Eclipse PLUS Creatinine Reagent Kit
HEMOSMART™ Gold Hemoglobin Test Strip
Eclipse PLUS HbA1c Reagent Kit
Eclipse PLUS Multi-Purpose Analyzer
BEACON Widal Positive Control
BEACON DIAGNOSTIC PVT., LTD
BEACON Widal Negative Control
BEACON DIAGNOSTIC PVT., LTD
UASURE II Uric Acid Control Solution
APEX BIOTECHNOLOGY CORP.
BEACON Stained Salmonella Antigen S. Paratyphi 'CH' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
BEACON Stained Salmonella Antigen S. Paratyphi 'BH' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
BEACON Stained Salmonella Antigen S. Paratyphi 'CO' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
BEACON Stained Salmonella Antigen S. Paratyphi 'AH' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
BEACON Stained Salmonella Antigen S. Paratyphi 'BO' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
BEACON Stained Salmonella Antigen S. Paratyphi 'AO' (Widal Slide & Tube Method)
BEACON DIAGNOSTIC PVT., LTD
Eclipse PLUS ACR Reagent Kit
APEX BIOTECHNOLOGY CORP.