Render Thromboelastogram Control (Control Level II) - Indonesia BPOM Medical Device Registration
Render Thromboelastogram Control (Control Level II) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205320537. The device is manufactured by RENDER 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
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 21, 2023
Expiry Date
Aug 22, 2025
Product Type
Automatic and Semi-Automatic Hematology Equipment
Multipurpose system for in vitro coagulation studies (for reagent & control)
Invitro Diagnostics
RENDER Functional Fibrinogen Assay (Coagulation Method)
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RENDER ITEG2+ Hemostatis Analyzer System and Accessories
Render ITEG4+ Hemostatis Analyzer System and Accessories
RENDER Platelet Aggregation Assay (Coagulation Method) For IAA2
RENDER Heparin Assay (Coagulation Method)
RENDER Thromboelastogram Control (Control Level I)
RENDER Kaolin Activation Assay (Coagulation Method)
RENDER Platelet Aggregation Assay (Coagulation Method) For IADA2
RENDER Rapid Activation Assay (Coagulation Method)
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