ELECSYS DIGIT 21-1 - Indonesia BPOM Medical Device Registration
ELECSYS DIGIT 21-1 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320374. The device is manufactured by ROCHE DIAGNOSTICS (SUZHOU) LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ROCHE INDONESIA.
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ELECSYS CYFRA 21-1
Risk Classification
Product Class
Kelas : 2
Manufacturer
ROCHE DIAGNOSTICS (SUZHOU) LTD.Country of Origin
China
Authorized Representative
PT. ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Dec 28, 2023
Expiry Date
Jul 17, 2028
Product Type
Tumor Antigen Immunologic Test System
Tumor-associated antigen immunological test system.
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