GENEX - Indonesia BPOM Medical Device Registration
GENEX is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302420308. The device is manufactured by BIOCOMPOSITES LIMITED from United Kingdom, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is TRANSMEDIC 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
BIOCOMPOSITES LIMITEDCountry of Origin
United Kingdom
Authorized Representative
TRANSMEDIC INDONESIAAR Address
Perkantoran Menara Era Unit G-01 JL.Senen Raya No.135-137 RT 00 RW 00, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Senen, Kel. Senen
Registration Date
Aug 26, 2024
Expiry Date
May 07, 2029
Product Type
Prosthetic Orthopedic Equipment
Resorbable calcium salt bone void filler device.
Non Electromedic Sterile
SSPC Delivery Catheter
CENTERPOINT SYSTEMS LLC
SANYOU Spinal Fusion Cage Implant
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Rod System (Thoracolumbar) 8
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Rod System (Thoracolumbar) 5
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Rod System (Thoracolumbar) 3
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Rod System (Thoracolumbar) 4
SHANGHAI SANYOU MEDICAL CO., LTD.
SANYOU Spinal Fusion Cage Instrument
SHANGHAI SANYOU MEDICAL CO., LTD.
MEICEN Thermoplastic Mask 2
GUANGDONG MEICEN MEDICAL EQUIPMENT CO., LTD.
EPIC™ Plus
ST. JUDE MEDICAL BRASIL LTDA
STRYKER Connected OR Hub System
NOVATECH INDUSTRIES