DIALINE Iron (Fe) - Indonesia BPOM Medical Device Registration
DIALINE Iron (Fe) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101125432. The device is manufactured by DIASYS DIAGNOSTIC SYSTEM, GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DIATRON PROMEDIKA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DIASYS DIAGNOSTIC SYSTEM, GMBHCountry of Origin
Germany
Authorized Representative
PT. DIATRON PROMEDIKAAR Address
Perkantoran Plaza Pasifik Blok B2/41 Jl. Boulevard Barat Raya, Kelapa Gading
Registration Date
Jan 15, 2025
Expiry Date
Sep 25, 2029
Product Type
Clinical Chemistry Test System
Iron (non-heme) test system (kit & cair)
Invitro Diagnostics
DIALINE HbA1c
DIALINE UIBC
DSI Phosphate FS
DSI HDL-c direct FS
DSI LDH 21 FS
DSI UREA STANDARD FS
DSI URIC ACID STANDARD FS
DSI CHOLESTEROL STANDARD FS
DSI ALBUMIN STANDARD FS
DSI CALCIUM STANDARD FS
DIALINE BioCal HDL/LDL
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE Bionorm L
DIASYS DAIGNOSTIC SYSTEMS GMBH.
DIALINE Triglycerides GPO - PAP
DIASYS DIAGNOSTIC SYSTEM GMBH.
DIALINE HbA1c
DIASYS DIAGNOSTIC SYSTEM, GMBH
DIALINE BioCal HbA1c
DIASYS DIAGNOSTIC SYSTEM GMBH.
DIALINE Bionorm Universal Control Serum
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE BioCAL Universal Calibrator
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE HDL-Chol Direct Selective
DIASYS DIAGNOSTIC SYSTEMS, GMBH.
DIALINE Magnesium
DIASYS DAIGNOSTIC SYSTEMS GMBH.
DIALINE BioPath Universal Control Serum
DIALINE DIAGNOSTIC SYSTEMS GMBH.

