DR DIAGNOSTIC FE Control II Positive Control Level 3 - Indonesia BPOM Medical Device Registration
DR DIAGNOSTIC FE Control II Positive Control Level 3 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101125627. 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 PT. GOLDEN MEDIKA MANDIRI.
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., LTDCountry of Origin
China
Authorized Representative
PT. GOLDEN MEDIKA MANDIRIAR Address
Jl. Raya Kalirungkut 27 Blok C-65
Registration Date
Sep 13, 2021
Expiry Date
Feb 14, 2024
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
DIRUI Control for Automatic Hematology Analyzer
DIRUI BCC-3600 Hematology Analyzer and Accessories
DIRUI CRP
DIRUI MALB
DIRUI CK-MB
GLORY DIAGNOSTICS – GD227 AUTO HEMATOLOGY ANALYZER AND ACCESSORIES
GLORY DIAGNOSTICS – LYSE 3600
GLORY DIAGNOSTICS – CLEANSER 3600
GLORY DIAGNOSTICS – GD907PLUS Auto-Chemistry Analyzer and Accessories
DIRUI Mg-XB
BIOTIME CRP Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME TSH Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME HbA1c Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME TT4 Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME MAU Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME TT3 Rapid Quantitative Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME FIA Analyzer FLI-100
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME TSH Rapid Quantitative Test (Chemiluminescence Immunoassay)
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME Dengue NS1 Antigen Rapid Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.
BIOTIME Dengue IgG/IgM Rapid Test
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.