RESOLUTE ONYX Zotralimus-Eluting Coronary Stent System - Indonesia BPOM Medical Device Registration
RESOLUTE ONYX Zotralimus-Eluting Coronary Stent System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503320231. The device is manufactured by MEDTRONIC IRELAND from Ireland, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. MEDTRONIC INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 3
Manufacturer
MEDTRONIC IRELANDCountry of Origin
Ireland
Authorized Representative
PT. 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
Jul 04, 2023
Expiry Date
Feb 07, 2028
Product Type
Prosthetic Cardiology Equipment
Drug eluting stent
Non Electromedic Sterile
EVOLUT FX Delivery Catheter System
MICRA™ AV2
MICRA™ VR2
Evolut FX Loading System
ENDURANT II Stent Graft System
MEDTRONIC C315 Delivery Catheter
VALIANT THORACIC Stent Graft with The Captivia Delivery System
IN. PACT ADMIRAL Paclitaxel-coated PTA Balloon Catheter
ATTAIN COMMAND + SUREVALVE Left Heart Delivery System
ATTAIN COMMAND ™ + SureValve ™ Guide Catheter for Left Heart Delivery
DLP Retrograde Cannula-Auto Inflate-PVC Body
VIANT MEDICAL INC.
BIS™ Advance Monitor
JABIL CIRCUIT SINGAPORE PTE LTD.
ATLANTIS Anterior Cervical Plate System
MEDTRONIC SOFAMOR DANEK MANUFACTURING
BIO-MEDICUS Pediatric Insertion Kit
MEDTRONIC MEXICO S.DE R.L.DE CV
BIO-MEDICUS Pediatric Arterial Cannula & Obturator
VIANT MEDICAL INC.
BIOMEDICUS Percutaneous Kit, Multi Stage Veneous Femoral
VIANT MEDICAL INC.
EXACT
MEDTRONIC MEXICO S. DE R.L. DE CV
EDM Catheters
MEDTRONIC MEXICO S. DE R.L. DE CV
STARFISH NS Heart Positioner
VIANT MEDICAL INC.
NEO Supra Instrument
CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.