RESPONS Cholesterol FS - Indonesia BPOM Medical Device Registration
RESPONS Cholesterol FS is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323184. The device is manufactured by DIASYS DIAGNOSTIC SYSTEMS GMBH. from Germany, 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
DIASYS DIAGNOSTIC SYSTEMS GMBH.Country of Origin
Germany
Authorized Representative
PT. SYSMEX INDONESIAAR Address
Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
Registration Date
Jun 04, 2023
Expiry Date
Mar 03, 2028
Product Type
Clinical Chemistry Test System
Cholesterol (total) test system (kit & cair)
Invitro Diagnostics
DIALINE BioCal HDL/LDL
DIALINE Alkaline Washing Solution
DIALINE Bionorm Universal Control Serum
DIALINE BioCAL Universal Calibrator
DIALINE Lipase Direct Colorimetric
DIALINE CK-MB IFCC/DGKC
DIALINE CK-NAC IFCC/DGKC
YUMIZEN C Urine Level 2 Control
DIALINE Cholesterol CHOD-PAP
DIALINE ALAT/ALT (GPT)
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 L2
DASH, INC.
SYSMEX CELLSHEATH
SYSMEX CORPORATION, ONO FACTORY.
XN-CHECK™ L3
DASH, INC.
SYSMEX CD4% easy count kit
EXBIO PRAHA, A.S.
SYSMEX Ca Cal S
SYSMEX CORPORATION, SEISHIN FACTORY.