KANGHUI Implant Spine - Indonesia BPOM Medical Device Registration
KANGHUI Implant Spine is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302712305. The device is manufactured by CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. 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 : 2
Manufacturer
CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.Country of Origin
China
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
Jan 30, 2025
Expiry Date
Feb 20, 2029
Product Type
Prosthetic Orthopedic Equipment
Spinal intervertebral body fixation orthosis.
Non Electromedic Non Sterile
NEO Supra Instrument
KANGHUI Plate and Screw System Instrument Sets
KANGHUI Variloc Pelvic Instrument
KANGHUI OMNAIL FEMORAL NAIL Instrument Set
KANGHUI Omnail Femoral Nail KGD II Instrument Set
KANGHUI OMNAIL FEMORAL NAIL Implant Set
KANGHUI General Spine System (CoCr Rod)
KANGHUI ECO MIS Minimally Invasive Spine System - Instrument Advance Set-Whole Set
KANGHUI ECO MIS Minimally Invasive Posterior Thoracolumbar Implant
ECO Posterior Thoracolumbar Fixation 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.
STARFISH NS Heart Positioner
VIANT MEDICAL INC.
EDM Catheters
MEDTRONIC MEXICO S. DE R.L. DE CV
EXACT
MEDTRONIC MEXICO S. DE R.L. DE CV
NEO Supra Instrument
CHANGZHOU KANGHUI MEDICAL INNOVATION CO., LTD.