ITI Knee Joint Prosthesis System - Indonesia BPOM Medical Device Registration
ITI Knee Joint Prosthesis System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302320877. The device is manufactured by BEIJING AK MEDICAL CO., LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ADHIRA MEDIKA PERSADA INTERNATIONAL.
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
BEIJING AK MEDICAL CO., LTDCountry of Origin
China
Authorized Representative
PT. ADHIRA MEDIKA PERSADA INTERNATIONALAR Address
Ruko Paramount Sparks B No. 17, Jl. Raya Kelapa Dua Gading Serpong
Registration Date
Sep 07, 2023
Expiry Date
May 25, 2028
Product Type
Prosthetic Orthopedic Equipment
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Non Electromedic Sterile
ZENER Metallic Bone Screw System 1
ZENER MEDTEC (CHANGZHOU) CO.,LTD
ZENER Metallic Bone Plate System 1
ZENER MEDTEC (CHANGZHOU) CO.,LTD
ZENER Metallic Bone Screw System 2
ZENER MEDTEC (CHANGZHOU) CO., LTD.
ZENER Metallic Intramedullary Nails System
ZENER MEDTEC (CHANGZHOU) CO.,LTD
ZENER Metallic Bone Plate System 3
ZENER MEDTEC (CHANGZHOU) CO.,LTD
ZENER Metallic Bone Plate System 2
ZENER MEDTEC (CHANGZHOU) CO.,LTD
ZENER Kyphoplasty Tool Kit
ZENER MEDTEC (CHANGZHOU) CO., LTD.
ZENER GENERAL SPINAL SYSTEM 2
ZENER MEDTEC (CHANGZHOU) CO., LTD.
ZENER GENERAL SPINAL SYSTEM
ZENER MEDTEC (CHANGZHOU) CO., LTD.
ITI Hip Joint Prosthesis System
BEIJING AK MEDICAL CO., LTD.

