HISCL Troponin T hs Assay Kit - Indonesia BPOM Medical Device Registration
HISCL Troponin T hs Assay Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101121378. The device is manufactured by SYSMEX CORPORATION, SEISHIN FACTORY. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is SYSMEX 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
SYSMEX CORPORATION, SEISHIN FACTORY.Country of Origin
Japan
Authorized Representative
SYSMEX INDONESIAAR Address
Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
Registration Date
Jan 22, 2025
Expiry Date
Jan 16, 2028
Product Type
Clinical Chemistry Test System
Creatine phosphokinase/creatine kinase or isoenzymes test system(kit & cair)
Invitro Diagnostics
SYSMEX Ca Cal S
HISCL โข Insulin Assay Kit
HISCLโข HBsAg Assay Kit
HISCL HBsAg Calibrator
SYSMEX Control Viratrol
HISCL Substrate Reagent Set
SYSMEX HBV IMMUNOASSAY CONTROL
HISCL Immuno Multi Control
HISCLโข Insulin Calibrator
HISCL Troponin T hs Calibrator
STROMATOLYSER -FB
SYSMEX CORPORATION, ONO FACTORY.
POCH-PACK D PPD - 300A
SYSMEX CORPORATION, ONO FACTORY.
Eightcheck-3WP-L
DASH, INC.
CELLPACK
SYSMEX CORPORATION, ONO FACTORY.
STROMATOLYSER-4DL
SYSMEX CORPORATION, ONO FACTORY.
HISCL HBeAg Assay Kit
JAPAN LYOPHILIZATION LABORATORY.
SYSMEX CELLPACK โข DFL
SYSMEX ASIA PACIFIC PTE., LTD.
TruLab Urine Level 2
DIASYS DIAGNOSTIC SYSTEMS GMBH
CELLPACK โข DCL
SYSMEX ASIA PACIFIC PTE., LTD.
TruLab Urine Level 1
DIASYS DIAGNOSTIC SYSTEMS GMBH

