AFFINITY PIXIE Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface - Indonesia BPOM Medical Device Registration
AFFINITY PIXIE Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20504020824. The device is manufactured by MEDTRONIC PERFUSION SYSTEMS from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is MEDTRONIC INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
MEDTRONIC PERFUSION SYSTEMSCountry of Origin
United States
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
Oct 11, 2023
Expiry Date
Feb 07, 2028
Product Type
Surgical Cardiology Equipment
Cardiopulmonary bypass oxygenator.
Non Electromedic Sterile
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