YHLO UNICELL -cTnI/CK-MB/Myo - Indonesia BPOM Medical Device Registration
YHLO UNICELL -cTnI/CK-MB/Myo is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101120382. The device is manufactured by SHENZHEN YHLO BIOTECH CO,,LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZHEN YHLO BIOTECH CO,,LTDCountry of Origin
China
Authorized Representative
PT. FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Jan 18, 2021
Expiry Date
Dec 31, 2023
Product Type
Clinical Chemistry Test System
Creatine phosphokinase/creatine kinase or isoenzymes test system (card)
Invitro Diagnostics
YHLO UNICELL-cTnI
YHLO UNICELL CK-MB
YHLO UNICELL-NT-proBNP
YHLO iFlash Toxo IgG (CLIA)
YHLO iFlash CMV IgG (CLIA)
YHLO iFlash Anti TP (Antibody To Treponema Pallidum) CLIA
YHLO UNICELL D-DIMER
YHLO iFlash Free PSA (CLIA)
YHLO iFlash CEA
YHLO iFlash CA 19-9
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SM Control Hematology Analyzer for 5 Diff
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SM Control Hematology Analyzer for 5 Diff (Normal Level)
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SM 420 Automatic Chemistry Analyzer and Accessories
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