SYSMEX Ca Cal S - Indonesia BPOM Medical Device Registration
SYSMEX Ca Cal S is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208501937. 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 PT. 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
PT. SYSMEX INDONESIAAR Address
Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
Registration Date
Nov 26, 2024
Expiry Date
Jan 28, 2026
Product Type
Hematological Reagents
Calibrator for hemoglobin or hematocrit measurement.
Invitro Diagnostics
HISCL Troponin T hs Assay Kit
HISCL ™ Insulin Assay Kit
HISCL™ HBsAg Assay Kit
HISCL HBsAg Calibrator
SYSMEX Control Viratrol
HISCL Substrate Reagent Set
SYSMEX HBV IMMUNOASSAY CONTROL
HISCL Immuno Multi Control
HISCL™ Insulin Calibrator
HISCL Troponin T hs Calibrator
SYSMEX Automated Blood Coagulation Analyzer CN-6000
SYSMEX CORPORATION
XN CAL PF
DASH, INC.
SULFOLYSER
SYSMEX CORPORATION, ONO FACTORY.
POCH-PACK L PPL-200A
SYSMEX CORPORATION, ONO FACTORY.
EIGHTCHECK-3WP-H
DASH, INC.
XN-CHECK™ L3
DASH, INC.
SYSMEX CELLSHEATH
SYSMEX CORPORATION, ONO FACTORY.
XN-CHECK L2
DASH, INC.
SYSMEX CD4% easy count kit
EXBIO PRAHA, A.S.
JEOL CA-21391 RAMINI RACK HANDLER
JEOL YAMAGATA CO., LTD.