BIOMAJESTY UIBC FS - Indonesia BPOM Medical Device Registration
BIOMAJESTY UIBC FS is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101020643. 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 SYSMEX INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DIASYS DIAGNOSTIC SYSTEMS, GMBH.Country of Origin
Germany
Authorized Representative
SYSMEX INDONESIAAR Address
Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13
Registration Date
Dec 24, 2021
Expiry Date
Sep 17, 2026
Product Type
Clinical Chemistry Test System
Iron (non-heme) test system (kit & cair)
Invitro Diagnostics
DIALINE HDL-Chol Direct Selective
DIALINE LDL - CHOL
BIOMAJESTY Cholesterol FS
BIOMAJESTY Urea FS
PROLINE - b CK-MB FS
BIOMAJESTY Pancreatic Amylase CC FS
BIOMAJESTY LDL-C Select FS
BIOMAJESTY Cholinesterase FS
BIOMAJESTY Apolipoprotein A1 FS
DIALINE Creatinine Jaffe-Method
HISCL Troponin T hs Assay Kit
SYSMEX CORPORATION, SEISHIN FACTORY.
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 ™ DFL
SYSMEX ASIA PACIFIC PTE., LTD.
TruLab Urine Level 2
DIASYS DIAGNOSTIC SYSTEMS GMBH
TruLab Urine Level 1
DIASYS DIAGNOSTIC SYSTEMS GMBH