DIRUI BF-FDO Lyse - Indonesia BPOM Medical Device Registration
DIRUI BF-FDO Lyse is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208810175. The device is manufactured by DIRUI INDUSTRIAL 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
DIRUI INDUSTRIAL CO., LTD.Country of Origin
China
Authorized Representative
PT. FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Oct 19, 2023
Expiry Date
Jul 01, 2028
Product Type
Hematological Reagents
Red cell lysing reagent.
Invitro Diagnostics
DIRUI Negative Control for Urine Sediment Analyzer
DIRUI HbA1C-s
DIRUI Prothrombin Time Detection Kit
DIRUI Positive Control for Urine Sediment Analyzer
DIRUI ALP
DIRUI LDH
DIRUI C-REACTIVE PROTEIN REGENT KIT
DIRUI Focus
DIRUI CS-680 Auto-Chemistry Analyzer
DIRUI Control for Hematology Analyzer
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SM – 700 Automatic Chemistry Analyzer
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