UNITED IMAGING Medical Linear Accelerator System - Indonesia BPOM Medical Device Registration
UNITED IMAGING Medical Linear Accelerator System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21502420031. The device is manufactured by SHANGHAI UNITED IMAGING HEALTHCARE CO,. LTD from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is FOKUS DIAGNOSTIC 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
SHANGHAI UNITED IMAGING HEALTHCARE CO,. LTDCountry of Origin
China
Authorized Representative
FOKUS DIAGNOSTIC INDONESIAAR Address
Jl. Jatipadang Raya No.9A, RT.6/RW.4, Kelurahan Jatipadang, Kecamatan Pasar Minggu, Kota Jakarta Selatan, DKI Jakarta 12540
Registration Date
Jul 29, 2024
Expiry Date
Nov 20, 2028
Product Type
Therapeutic Radiology Equipment
Medical charged-particle radiation therapy system.
Electromedic Radiation
DxFLEX with Autoloader and Accessories
BECKMAN COULTER BIOTECHNOLOGY (SUZHOU) CO., LTD.
ClearLLab Control Cells Abnormal
DASH, INC.
ClearLLab Control Cells Normal
DASH, INC.
FOCUS Dengue NS1 Antigen Cassette
ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.
FOKUS Febrile Antigen O-B Paratyphi
PULSE SCIENTIFIC INC.
IOTest 3 Lysing Solution
IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY.
IOTest 3 Fixative Solution
IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY.
CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5
BECKMAN COULTER, INC.
UNITED IMAGING Digital Mammography X-ray Imaging System
SHANGHAI UNITED IMAGING HEALTHCARE CO,. LTD
XENTA Procalcitonin (PCT) Detection Kit (Fluorescence Immuno chromatography)
XENTA BIOMEDICAL SCIENCE CO., LTD

