Maglumi™ Light Check - Indonesia BPOM Medical Device Registration
Maglumi™ Light Check is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204915556. The device is manufactured by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. MULTIMEDILAB KARYAMANDIRI.
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Risk Classification
Product Class
Kelas : 1
Country of Origin
China
Authorized Representative
PT. MULTIMEDILAB KARYAMANDIRIAR Address
GP plaza lantai 3 unit 6, jalan Gelora II No. 01
Registration Date
Jul 21, 2022
Expiry Date
Dec 31, 2025
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
MAGLUMI HAV IgM (CLIA)
MAGLUMI Toxo IgG (CLIA)
MAGLUMI™ Total PSA (CLIA)
MAGLUMI Rubella IgM (CLIA)
MAGLUMI CMV IgM (CLIA)
MAGLUMI™ Estradiol (CLIA)
MAGLUMI™ Ferritin (CLIA)
MAGLUMI™ T4 (CLIA)
MAGLUMI 4000 CLIA Analyzer and Accessories
MAGLUMI 800 CLIA Analyzer and Accessories
AGAPPE Mispa-i3 C3
AGAPPE DIAGNOSTICS LTD.
AGAPPE Mispa-i3 C4
AGAPPE DIAGNOSTICS LTD.
DIAGNOSYF 431 CA Automatic Chemistry Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
DIAGNOSYF 200 CA Automatic Chemistry Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
DIAGNOSYF SF 590 5-Diff Hematology Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
DIAGNOSYF SF 70 3-Diff Hematology Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
MAGLUMI Wash Concentrate
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI®IGF-I (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. ( SNIBE )
Anti-HCV MAGLUMI ® (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI ® Aldosterone (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. ( SNIBE )