On-X® Prosthetic Heart Valve Instruments - Indonesia BPOM Medical Device Registration
On-X® Prosthetic Heart Valve Instruments is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10504320190. The device is manufactured by ON-X LIFE TECHNOLOGIES, INC. from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 1
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
Dec 04, 2023
Expiry Date
Mar 10, 2028
Product Type
Surgical Cardiology Equipment
Cardiovascular surgical instruments.
Non Electromedic Non Sterile
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On-X Aortic Prosthetic Heart Valve – Extended Holder
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