GOLDSITE HbA1c Calibrator - Indonesia BPOM Medical Device Registration
GOLDSITE HbA1c Calibrator is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101422179. The device is manufactured by GOLDSITE DIAGNOSTICS INC. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is EN. RIOCA MEDICA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
GOLDSITE DIAGNOSTICS INC.Country of Origin
China
Authorized Representative
EN. RIOCA MEDICAAR Address
Komplek Pesona Indah Kapuk Blok A6 Jl. Kapuk Kamal Raya Kav.20A Lantai 3
Registration Date
Oct 25, 2024
Expiry Date
Jan 15, 2027
Product Type
Clinical Chemistry Test System
Calibrator (cair)
Invitro Diagnostics
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EXIAS e|1 QC-2 Quality Control Level 2
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EXIAS e|1 Cartridge 150
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EXIAS e|1 Cartridge 600
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EXIAS e|1 Analyzer and Accessories
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EXIAS e|1 QC-1 Quality Control Level 1
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EXIAS e|1 Cartridge 300
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EXIAS e|1 Cartridge 150 oQC
EXIAS MEDICAL GMBH
EXIAS e|1 Cartridge 300 oQC
EXIAS MEDICAL GMBH

