Solitaire ™ X Revascularization Device - Indonesia BPOM Medical Device Registration
Solitaire ™ X Revascularization Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21003918942. The device is manufactured by MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MEDTRONIC INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULARCountry of Origin
United States
Authorized Representative
PT. MEDTRONIC INDONESIAAR Address
Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda, Desa/Kelurahan Kebayoran Lama Utara, Kec. Kebayoran Lama
Registration Date
Mar 07, 2024
Expiry Date
Feb 28, 2028
Product Type
Therapeutic Neurology Equipment
Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
Non Electromedic Non Sterile
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