BECKMAN COULTER HbA1c Advanced - Indonesia BPOM Medical Device Registration
BECKMAN COULTER HbA1c Advanced is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207220104. The device is manufactured by ROCHE DIAGNOSTICS GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DHH TRADING INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ROCHE DIAGNOSTICS GMBHCountry of Origin
Germany
Authorized Representative
PT. DHH TRADING INDONESIAAR Address
Revenue Tower 19F, Jl. Jenderal Sudirman No. 52-53, Prov. DKI Jakarta, Kota Adm. Jakarta Selatan, Kec Kebayoran Baru, Kel Senayan
Registration Date
Jun 28, 2024
Expiry Date
Feb 10, 2026
Product Type
Haematology Package and Kit
Glycosylated hemoglobin assay.
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