MAGLUMI Reaction Module - Indonesia BPOM Medical Device Registration
MAGLUMI Reaction Module is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10102715611. 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 MULTIMEDILAB KARYAMANDIRI.
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Risk Classification
Product Class
Kelas : 1
Country of Origin
China
Authorized Representative
MULTIMEDILAB KARYAMANDIRIAR Address
GP plaza lantai 3 unit 6, jalan Gelora II No. 01
Registration Date
Jul 18, 2022
Expiry Date
Dec 31, 2025
Product Type
Clinical Laboratory Equipment
General purpose laboratory equipment labeled or promoted for a specific medical use.
Invitro Diagnostics
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MAGLUMI EPO (CLIA)
MAGLUMI Osteocalcin (CLIA)
MAGLUMI ICA (CLIA)
MAGLUMI Anti-Cardiolipin IgM (CLIA)
MAGLUMI Anti-Cardiolipin (CLIA)
MAGLUMI Anti-Cardiolipin IgG (CLIA)
MAGLUMI Anti-ฮฒ2-Glycoprotein 1 IgM (CLIA)
MAGLUMI Anti-ฮฒ2-Glycoprotein 1 IgG (CLIA)
MAGLUMI Anti-Cardiolipin IgA (CLIA)
AGAPPE Albumin Mispa CCXL, CXLpro, CX4
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MAGLUMI ยฎ HBsAg (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI ยฎ ON SCREEN (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI ยฎ Total T4 (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
Agappe HDL-C DIRECTCCXL,CXLpro,CX4
AGAPPE DIAGNOSTICS LTD.
AGAPPE ENZYMATIC CREATININE CCXL,CXLpro,CX4
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MAGLUMI ยฎ TRAb (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
MAGLUMI ยฎ Total ฮฒ HCG (CLIA)
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.
AGAPPE GLUCOSE MISPA CCXL
AGAPPE DIAGNOSTICS LTD.
AGAPPE SGPT CCXL,CXLpro,CX4
AGAPPE DIAGNOSTICS LTD.