ABX Pentra HDL Direct CP - Indonesia BPOM Medical Device Registration
ABX Pentra HDL Direct CP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101324644. The device is manufactured by SEKISUI DIAGNOSTICS P.E.I. INC from Canada, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is HORIBA INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INCCountry of Origin
Canada
Authorized Representative
HORIBA INDONESIAAR Address
Jl. Jalur Sutera , Blok. 20A, No. 16 - 17, Kel. Kunciran, Kec. Pinang
Registration Date
Dec 27, 2023
Expiry Date
Nov 15, 2028
Product Type
Clinical Chemistry Test System
Lipoprotein test system (kit & cair)
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