DIRUI Sample Processing System - Indonesia BPOM Medical Device Registration
DIRUI Sample Processing System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10102320674. The device is manufactured by DIRUI INDUSTRIAL CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is DIRUI MEDICAL 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 : 1
Manufacturer
DIRUI INDUSTRIAL CO., LTD.Country of Origin
China
Authorized Representative
DIRUI MEDICAL INDONESIAAR Address
Kompleks Pergudangan Green Sedayu Bizpark Cakung, Blok GS 6 Nomor 26
Registration Date
Oct 25, 2023
Expiry Date
Jun 27, 2028
Product Type
Clinical Laboratory Equipment
General purpose laboratory equipment labeled or promoted for a specific medical use.
Invitro Diagnostics
DIRUI Negative Control for Urine Sediment Analyzer
DIRUI HbA1C-s
DIRUI Prothrombin Time Detection Kit
DIRUI Positive Control for Urine Sediment Analyzer
DIRUI ALP
DIRUI LDH
DIRUI C-REACTIVE PROTEIN REGENT KIT
DIRUI Focus
DIRUI CS-680 Auto-Chemistry Analyzer
DIRUI Control for Hematology Analyzer
DIRUI C-REACTIVE PROTEIN REGENT KIT
DIRUI INDUSTRIAL CO., LTD.
DIRUI Fluorescent Calibrator
DIRUI INDUSTRIAL CO., LTD.
DIRUI H-800 Urine Analyzer and Accesories
DIRUI INDUSTRIAL CO., LTD.
DIRUI Control for Body Liquid
DIRUI INDUSTRIAL CO., LTD.
DIRUI CK-MB
DIRUI INDUSTRIAL CO., LTD.
DIRUI BCC-3900 Automatic Hematology Analyzer and accessories
DIRUI INDUSTRIAL CO., LTD.
DIRUI DBIL
DIRUI INDUSTRIAL CO., LTD.
DIRUI BF-SLS-II Lyse
DIRUI INDUSTRIAL CO., LTD.
DIRUI UA
DIRUI INDUSTRIAL CO., LTD.
DIRUI H-100 Urine Analyzer and Accesories
DIRUI INDUSTRIAL CO., LTD.

