PIPELINE Flex Embolization Device - Indonesia BPOM Medical Device Registration
PIPELINE Flex Embolization Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31003121275. The device is manufactured by MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR from United States, 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
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULARCountry of Origin
United States
Authorized Representative
PT. MEDTRONIC INDONESIAAR Address
Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda
Registration Date
Mar 03, 2021
Expiry Date
Jan 13, 2026
Product Type
Therapeutic Neurology Equipment
Neurovascular embolization device.
Non Electromedic Sterile
MIRAGE ™ .008 Hydrophilic Guidewire
ONYX™ Liquid Embolic System (LES)
Solitaire ™ X Revascularization Device
REACT™ 71 Catheter
REACT™ 68 Catheter
PIPELINE Flex Embolization Device with Shield Technology
HYPERFORM Occlusion Balloon System
Pipeline™ Vantage Embolization Device with Shield Technology™
ONYX Liquid Embolic System
AXIUM™ Prime Detachable Coil System
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.