RANDOX Coagulation Control - Level 3 (COAG CONTROL 3) - Indonesia BPOM Medical Device Registration
RANDOX Coagulation Control - Level 3 (COAG CONTROL 3) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421421. The device is manufactured by RANDOX LABORATORIES LIMITED from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is CEKINDO BUSINESS INTERNATIONAL.
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
RANDOX LABORATORIES LIMITEDCountry of Origin
United Kingdom
Authorized Representative
CEKINDO BUSINESS INTERNATIONALAR Address
CEKINDO BUSINESS INTERNATIONAL
Registration Date
Jul 29, 2024
Expiry Date
Nov 08, 2028
Product Type
Clinical Chemistry Test System
Quality control material (assayed and unassayed) (cair)
Invitro Diagnostics
RANDOX Total Antioxidant Status (TAS)
RANDOX Glutathione Peroxide (RANSEL)
RANDOX Ransel Control
RANDOX Glutathione Peroxide (RANSEL)
RANDOX Ransel Calibrator (RANSEL CAL)
RANDOX Serology III Positive Control (Serology III Control +)
RANDOX Serology I Positive Control (Serology I Control +)
RANDOX Serology II Positive Control (Serology II Control +)
RANDOX Serology Negative Control (Serology Control -)
RANDOX Total Antioxidant Status (TAS CONTROL)
Health Tree Pulse Oximeter
GUANGDONG HEALTHTREE MEDICAL TECHNOLOGY CO., LTD.
Imagemate MR Injection System
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.
MICROLIFE Mesh Nebulizer
SHENZEN BI-RICH MEDICAL DEVICES CO. LIMITED
Imagemate DSA Injection System
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.
ADDCARE Fully Automated Blood Grouping System
YANTAI ADDCARE BIO-TECH CO., LTD.
Target Madical ™ Disposable Introducer Kit
BEIJING TARGET MEDICAL TECHNOLOGIES INC
ADDCARE Fully Automated CLIA Workstation
YANTAI ADDCARE BIO-TECH CO., LTD
ADDCARE Fully Automated CLIA Workstation
YANTAI ADDCARE BIO-TECH CO., LTD
SMARTXIDE PRO
DEKA M.E.L.A S.R.L.
EXACTIVE PRO Blood Glucose Control Solution
MICROTECH MEDICAL (HANGZHOU) CO., LTD