ABACUS 5 Hematology Analyzer - Indonesia BPOM Medical Device Registration
ABACUS 5 Hematology Analyzer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205111209. The device is manufactured by DIATRON MI., PLC. from Hungary, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DIATRON PROMEDIKA.
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
DIATRON MI., PLC.Country of Origin
Hungary
Authorized Representative
PT. DIATRON PROMEDIKAAR Address
Perkantoran Plaza Pasifik Blok B2/41 Jl. Boulevard Barat Raya, Kelapa Gading
Registration Date
Sep 21, 2020
Expiry Date
Jul 03, 2025
Product Type
Automatic and Semi-Automatic Hematology Equipment
Automated differential cell counter.
Invitro Diagnostics
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 BioCAL Universal Calibrator
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE HDL-Chol Direct Selective
DIASYS DIAGNOSTIC SYSTEMS, GMBH.
DIALINE Magnesium
DIASYS DAIGNOSTIC SYSTEMS GMBH.
DIALINE Bionorm Universal Control Serum
DIASYS DIAGNOSTIC SYSTEMS GMBH.
DIALINE BioPath Universal Control Serum
DIALINE DIAGNOSTIC SYSTEMS GMBH.

