MINDRAY U-11 Urine Test Strips - Indonesia BPOM Medical Device Registration
MINDRAY U-11 Urine Test Strips is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101918958. The device is manufactured by ACON BIOTECH (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is MINDRAY MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ACON BIOTECH (HANGZHOU) CO., LTD.Country of Origin
China
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 08, 2024
Expiry Date
Jul 04, 2029
Product Type
Clinical Chemistry Test System
Multi parameter clinical chemistry test system
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