MINDRAY BC-3D Hematology Control Level N - Indonesia BPOM Medical Device Registration
MINDRAY BC-3D Hematology Control Level N is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208126177. The device is manufactured by R&D SYSTEMS INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is MINDRAY MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
R&D SYSTEMS INC.Country of Origin
United States
Authorized Representative
MINDRAY MEDICAL INDONESIAAR Address
Menara DEA II Lt.17, Jl. Mega Kuningan Barat Kav.E4.3 No.1-2, Kel. Kuningan Timur, Kec.Setiabudi Kawasan Mega Kuningan, Jakarta Selatan
Registration Date
Oct 18, 2021
Expiry Date
Jun 29, 2025
Product Type
Hematological Reagents
Hematology quality control mixture.
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