SEIMITSU Direct Bilirubin - Indonesia BPOM Medical Device Registration
SEIMITSU Direct Bilirubin is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101422105. The device is manufactured by ONE CO.,LTD from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SEIMITSU DIAGNOSTICS.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ONE CO.,LTDCountry of Origin
Japan
Authorized Representative
PT. SEIMITSU DIAGNOSTICSAR Address
Harton Tower 7th Floor, Jl. Boulevard Artha Gading, Kel. Kelapa Gading Barat, Kec. Kelapa Gading, Jakarta Utara.
Registration Date
Oct 21, 2024
Expiry Date
Oct 20, 2027
Product Type
Clinical Chemistry Test System
Bilirubin (total or direct) test system (kit & cair)
Invitro Diagnostics
Seimitsu Total Protein
SEIMITSU Ureum
Seimitsu Uric Acid
SEIMITSU Total Bilirubin
Seimitsu ALB
Seimitsu HbA1c
SEIMITSU Triglycerides (TG)
Seimitsu ALP IFCC
SEIMITSU HbA1c Control Set
SEIMITSU Lipid Calibrator
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 ALB
ONE CO.,LTD
Seimitsu HbA1c
ONE CO.,LTD
SEIMITSU LDH IFCC
A CO., LTD.
SEIMITSU CRP-F
A CO., LTD.