SOGATA Patient Monitor - Indonesia BPOM Medical Device Registration
SOGATA Patient Monitor is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20502025578. The device is manufactured by EDAN INSTRUMENTS, INC., from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SETIA MANGGALA ABADI.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
EDAN INSTRUMENTS, INC.,Country of Origin
China
Authorized Representative
PT. SETIA MANGGALA ABADIAR Address
PERKANT. KENCANA NIAGA BLOK D1 NO. 2-U TAMAN ARIES, Desa/Kelurahan Meruya Utara, Kec. Kembangan, Kota Adm. Jakarta Barat, Provinsi DKI Jakarta, Kode Pos: 11620
Registration Date
Jul 27, 2023
Expiry Date
Feb 28, 2026
Product Type
Monitoring Cardiology Equipment
Cardiac monitor (including cardiotachometer and rate alarm).
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