SEIMITSU Total Bilirubin (T-BIL) - Indonesia BPOM Medical Device Registration
SEIMITSU Total Bilirubin (T-BIL) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101024933. The device is manufactured by A CO., LTD. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SEIMITSU DIAGNOSTICS.
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
A CO., LTD.Country of Origin
Japan
Authorized Representative
PT. SEIMITSU DIAGNOSTICSAR Address
MAYAPADA TOWER LANTAI 11 JL. JEND. SUDIRMAN KAV.28
Registration Date
Jul 11, 2023
Expiry Date
Jun 10, 2025
Product Type
Clinical Chemistry Test System
Bilirubin (total and unbound) in the neonate test system (kit & cair)
Invitro Diagnostics
SEIMITSU CRP-F
SEIMITSU LDH IFCC
SEIMITSU Total Cholesterol (TC)
SEIMITSU Cholesterol HDL
SEIMITSU Glucose (GLU)
SEIMITSU LDL Cholesterol
SEIMITSU SGOT (AST)
SEIMITSU SGPT (ALT)
SEIMITSU Multi Calibrator
SEIMITSU Direct Bilirubin (D-BIL)
SEIMITSU DIAGNOSTICS SCA 300 Chemistry Analyzer and Accessories
ZHUHAI SENLONG BIOTECH CO., LTD
SEIMITSU DIAGNOSTICS Auto Hematology Analyzer
SHENZHEN HETO MEDICAL TECH CO.,LTD.
Seimitsu Total Protein
ONE CO.,LTD
SEIMITSU Ureum
ONE CO.,LTD
Seimitsu Uric Acid
ONE CO.,LTD
SEIMITSU Total Bilirubin
ONE CO.,LTD
SEIMITSU Direct Bilirubin
ONE CO.,LTD
Seimitsu ALB
ONE CO.,LTD
Seimitsu HbA1c
ONE CO.,LTD
SEIMITSU CRP-F
A CO., LTD.

