MAGLUMI™ Estradiol (CLIA) - Indonesia BPOM Medical Device Registration
MAGLUMI™ Estradiol (CLIA) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101914725. The device is manufactured by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MULTIMEDILAB KARYAMANDIRI.
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
Country of Origin
China
Authorized Representative
PT. MULTIMEDILAB KARYAMANDIRIAR Address
GP plaza lantai 3 unit 6, jalan Gelora II No. 01
Registration Date
Nov 21, 2022
Expiry Date
Dec 31, 2025
Product Type
Clinical Chemistry Test System
Estradiol test system (kit & cair)
Invitro Diagnostics
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MAGLUMI™ Ferritin (CLIA)
MAGLUMI™ T4 (CLIA)
MAGLUMI 4000 CLIA Analyzer and Accessories
Maglumi™ Light Check
MAGLUMI 800 CLIA Analyzer and Accessories
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