Render ITEG4+ Hemostatis Analyzer System and Accessories - Indonesia BPOM Medical Device Registration
Render ITEG4+ Hemostatis Analyzer System and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205320545. The device is manufactured by RENDER BIOTECH CO., LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
RENDER 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
Nov 28, 2023
Expiry Date
Aug 22, 2025
Product Type
Automatic and Semi-Automatic Hematology Equipment
Coagulation instrument.
Invitro Diagnostics
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RENDER Heparin Assay (Coagulation Method)
RENDER Kaolin Activation Assay (Coagulation Method)
RENDER Platelet Aggregation Assay (Coagulation Method) For IADA2
RENDER Rapid Activation Assay (Coagulation Method)
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