OPTIMA XR646 HD - Indonesia BPOM Medical Device Registration
OPTIMA XR646 HD is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501915879. The device is manufactured by GE MEDICAL SYSTEMS, LLC from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. GE OPERATIONS INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
GE MEDICAL SYSTEMS, LLCCountry of Origin
United States
Authorized Representative
PT. GE OPERATIONS INDONESIAAR Address
South Quarter Tower B, Lantai 18-19 Jl. R.A. Kartini, Kav. 8 Kel. Cilandak Barat, Kec. Cilandak Jakarta Selataran 12430
Registration Date
Aug 14, 2023
Expiry Date
May 30, 2028
Product Type
Diagnostic Radiology Equipment
Stationary x-ray system.
Electromedic Radiation
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