SERENA ™ Quad CRT-P MRI SureScan ™ - Indonesia BPOM Medical Device Registration
SERENA ™ Quad CRT-P MRI SureScan ™ is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503716276. The device is manufactured by MEDTRONIC EUROPE S.A.R.L. from Switzerland, 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 EUROPE S.A.R.L.Country of Origin
Switzerland
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
Feb 21, 2024
Expiry Date
Feb 07, 2028
Product Type
Prosthetic Cardiology Equipment
Implantable pacemaker pulse generator.
Non Radiation Electromedics
MIRRO MRI DR SURESCAN DDME3D1
REVEAL LINQ ™
EVERA MRI S VR SureScan
MIRRO MRI™ VR SureScan™
PRIMO MRI™ VR SureScan™
MIRRO MRI DR SureScan
MEDTRONIC Mirro MRI VR SureScan
PRIMO MRI™ DR SureScan™
PRIMO MRI™ DR SureScan™
PRIMO MRI™ VR SureScan™
NG BIO-MEDICUS Pediatric Venous Cannula and Introducers
MEDTRONIC MEXICO S DE R.L DE CV
NG Bio-Medicus Adult Arterial/Internal Jugular Cannula Kits
MEDTRONIC MEXICO S DE R.L DE CV
AFFINITY CP Centrifugal Blood Pump
MEDTRONIC MEXICO S. DE R.L. DE CV
MEDTRONIC Lumboperitonial Shunt
MEDTRONIC DOMINICANA (MANUFACTURA) S.A.
MEDTRONIC CSF Valves And Buttons
MEDTRONIC DOMINICANA (MANUFACTURA) S.A.
MEDTRONIC Ventricular Catheters
MEDTRONIC NEUROSURGERY
MEDTRONIC Shunt Accessories
MEDTRONIC DOMINICANA (MANUFACTURA) S.A.
MEDTRONIC Shunt Kits
MEDTRONIC DOMINICANA (MANUFACTURA) S.A.
MEDTRONIC EDM Lumbar
MEDTRONIC MEXICO S. DE R.L. DE CV
CG Future Sizer Sets
MEDTRONIC HEART VALVE DIVISION

