DIRUI MALB - Indonesia BPOM Medical Device Registration
DIRUI MALB is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101916217. The device is manufactured by DIRUI INDUSTRIAL CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is FAITHFUL MEDICAL GRACE.
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
DIRUI INDUSTRIAL CO., LTD.Country of Origin
China
Authorized Representative
FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Nov 07, 2022
Expiry Date
Jun 14, 2025
Product Type
Clinical Chemistry Test System
Urinary protein or albumin (nonquantitative) test system (kit & cair)
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 LDH
DIRUI ALP
DIRUI C-REACTIVE PROTEIN REGENT KIT
DIRUI Focus
DIRUI CS-680 Auto-Chemistry Analyzer
DIRUI Control for Hematology Analyzer
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