EVOLUT FX Transcatheter Aortic Valve - Indonesia BPOM Medical Device Registration
EVOLUT FX Transcatheter Aortic Valve is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503420187. The device is manufactured by MEDTRONIC MEXICO S. DE R.L. DE C.V. from Mexico, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is MEDTRONIC INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
MEDTRONIC MEXICO S. DE R.L. DE C.V.Country of Origin
Mexico
Authorized Representative
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
Nov 13, 2024
Expiry Date
Feb 20, 2029
Product Type
Prosthetic Cardiology Equipment
Prosthesis Percutaneously Delivered Aortic Valve
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