RESPONS LDL-C direct FS - Indonesia BPOM Medical Device Registration
RESPONS LDL-C direct FS is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323427. 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.
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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
Jul 07, 2023
Expiry Date
Mar 03, 2028
Product Type
Clinical Chemistry Test System
Lipoprotein test system (kit & cair)
Invitro Diagnostics
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DIALINE CK-NAC IFCC/DGKC
YUMIZEN C Urine Level 2 Control
DIALINE Cholesterol CHOD-PAP
DIALINE ALAT/ALT (GPT)
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