GEMSS Mobile Surgical Fluoroscopic X-Ray System - Indonesia BPOM Medical Device Registration
GEMSS Mobile Surgical Fluoroscopic X-Ray System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501420267. The device is manufactured by GEMSS HEALTHCARE CO. LTD from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is SETIA ZAM MED.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
GEMSS HEALTHCARE CO. LTDCountry of Origin
Korea
Authorized Representative
SETIA ZAM MEDAR Address
Habitat Land Cibinong, blok R1 No. 2, 4, 6, 8 Jl.Kramat Raya - Cikaret Cibinong RT.04 RW.05, Kel. Tengah, Kec. Cibinong, Kab. Bogor, Prov. Jawa Barat
Registration Date
May 02, 2024
Expiry Date
Oct 24, 2028
Product Type
Diagnostic Radiology Equipment
Image-intensified fluoroscopic x-ray system.
Electromedic Radiation
