EVOLUT FX Delivery Catheter System - Indonesia BPOM Medical Device Registration
EVOLUT FX Delivery Catheter System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505420149. The device is manufactured by MEDTRONIC IRELAND from Ireland, 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 IRELANDCountry of Origin
Ireland
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 18, 2024
Expiry Date
Feb 20, 2029
Product Type
Therapeutic Cardiology Equipment
Percutaneous catheter for coronary use
Non Electromedic Sterile
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