MONO HbA1c (Glycated Hemoglobin) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories - Indonesia BPOM Medical Device Registration
MONO HbA1c (Glycated Hemoglobin) Rapid Quantitative Test (Immunofluorescence Assay) and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207320222. The device is manufactured by AEHEALTH LIMITED from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BINTANG MONO INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
AEHEALTH LIMITEDCountry of Origin
United Kingdom
Authorized Representative
PT. BINTANG MONO INDONESIAAR Address
TAMAN TEKNO BSD SEKTOR XI BLOK J 3 NOMOR 25
Registration Date
Dec 04, 2023
Expiry Date
Feb 03, 2026
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
Invitro Diagnostics
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