Zybio Automated Blood Coagulation Analyzer YX-2000 - Indonesia BPOM Medical Device Registration
Zybio Automated Blood Coagulation Analyzer YX-2000 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205420207. The device is manufactured by SHENZHEN THISTORY BIO-MEDICAL CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ZYBIO MEDICAL INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZHEN THISTORY BIO-MEDICAL CO., LTD.Country of Origin
China
Authorized Representative
PT. ZYBIO MEDICAL INDONESIAAR Address
Satrio Tower Unit 8, Lantai 14 No. 5 Bok C4, Jl. Prof. Dr, Satrio No. 7, Kel. Setiabudi, Kec. Kuningan Timur, Kota Jakarta Selatan, Prov. DKI Jakarta
Registration Date
Oct 01, 2024
Expiry Date
Jan 30, 2029
Product Type
Automatic and Semi-Automatic Hematology Equipment
Multipurpose system for in vitro coagulation studies.
Invitro Diagnostics
Zybio Automated Blood Coagulation Analyzer YX-3000
Zybio Antithrombin III Reagent Kit (Chromogenic Substrate Method)
Zybio Blood Coagulation Unassayed Controls
ZYBIO Probe Cleanser
ZYBIO Fibrinogen Reagent Kit (Clotting Method)
ZYBIO Activated Partial Thromboplastin Time Reagent Kit (Clotting Method)
ZYBIO Prothrombin Time Reagent Kit (Clotting Method)
ZYBIO Thrombin Time Reagent Kit (Clotting Method)
ZYBIO D-Dimer Controls
ZYBIO D-Dimer Reagent Kit (Immunoturbidimetric Assays)
ZYBIO FT4 Assay (Immunofluorescence)
ZYBIO INC.
ZYBIO Urinalysis Hybrid System Series U3601
ZYBIO INC.
ZYBIO H58 LD Lyse
ZYBIO INC.
ZYBIO H58 DR Diluent
ZYBIO INC.,
ZYBIO H58 FN Dye
ZYBIO INC
ZYBIO H58 FR Dye
ZYBIO INC.
Zybio Automated Blood Coagulation Analyzer YX-3000
SHENZHEN THISTORY BIO-MEDICAL CO., LTD.
Zybio Antithrombin III Reagent Kit (Chromogenic Substrate Method)
SHENZHEN THISTORY BIO-MEDICAL CO., LTD.
Zybio Blood Coagulation Unassayed Controls
SHENZHEN THISTORY BIO-MEDICAL CO., LTD.
ZYBIO Substrate
ZYBIO INC