STEALTH 360 Peripheral Orbital Atherectomy System - Indonesia BPOM Medical Device Registration
STEALTH 360 Peripheral Orbital Atherectomy System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30504420058. The device is manufactured by CARDIOVASCULAR SYSTEMS INCORPORATED from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. MAIN REVASS MEDIKA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
CARDIOVASCULAR SYSTEMS INCORPORATEDCountry of Origin
United States
Authorized Representative
PT. MAIN REVASS MEDIKAAR Address
Jl. Dewi Sartika No. 4B RT 004/007 Kel. Cililitan Kec. Kramat jati
Registration Date
May 31, 2024
Expiry Date
Jul 27, 2026
Product Type
Surgical Cardiology Equipment
Coronary atherectomy catheter
Non Electromedic Sterile
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