ON-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft - Indonesia BPOM Medical Device Registration
ON-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503520003. The device is manufactured by ON-X LIFE TECHNOLOGIES, INC. from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
ON-X LIFE TECHNOLOGIES, INC.Country of Origin
United States
Authorized Representative
PT. ANDAMAN MEDICAL INDONESIAAR Address
Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma
Registration Date
Jan 13, 2025
Expiry Date
Mar 10, 2028
Product Type
Prosthetic Cardiology Equipment
Replacement heart valve.
Non Electromedic Sterile
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