ACCU-CHEK Performance Set - Indonesia BPOM Medical Device Registration
ACCU-CHEK Performance Set is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101918066. The device is manufactured by SANMINA CORPORATION from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is ROCHE INDONESIA.
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ACCU-CHEK Performa Set
Risk Classification
Product Class
Kelas : 2
Manufacturer
SANMINA CORPORATIONCountry of Origin
United States
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Dec 09, 2019
Expiry Date
Aug 28, 2024
Product Type
Clinical Chemistry Test System
Glucose test system
Invitro Diagnostics
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