OEC One CFD - Indonesia BPOM Medical Device Registration
OEC One CFD is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501123490. The device is manufactured by GE HUALUN MEDICAL SYSTEMS CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is GE OPERATIONS 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
GE HUALUN MEDICAL SYSTEMS CO., LTD.Country of Origin
China
Authorized Representative
GE OPERATIONS INDONESIAAR Address
South Quarter Tower B, Lantai 18-19 Jl. R.A. Kartini, Kav. 8 Kel. Cilandak Barat, Kec. Cilandak Jakarta Selataran 12430
Registration Date
Jun 16, 2021
Expiry Date
May 07, 2025
Product Type
Diagnostic Radiology Equipment
Image-intensified fluoroscopic x-ray system.
Electromedic Radiation
OEC One ASD
OMNI Legend
GE Analog Radiography System
DEFINIUM Pace Select
NM/CT 850
NM/CT 870 DR
GE Discovery NM/CT 670 Pro
GE Optima IGS 330
GE Optima IGS 320
OEC Elite MiniView
OEC One ASD
GE HUALUN MEDICAL SYSTEMS CO., LTD.
Vivid T8
GE MEDICAL SYSTEMS (CHINA) CO., LTD.
Vivid T9
GE MEDICAL SYSTEMS (CHINA) CO., LTD.
SIGNA Champion
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
Voluson Expert 20
GE HEALTHCARE AUSTRIA GMBH & CO OG
Voluson Expert 22
GE HEALTHCARE AUSTRIA GMBH & CO OG
SIGNA Prime Elite
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
ViewPoint 6
GE HEALTHCARE GMBH
LOGIQ E10
GE ULTRASOUND KOREA, LTD.
Voluson Signature 20
GE ULTRASOUND KOREA, LTD.

