SELENIA Dimensions 3D System - Indonesia BPOM Medical Device Registration
SELENIA Dimensions 3D System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31501121554. The device is manufactured by HOLOGIC, INC from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. UROGEN ADVANCED SOLUTIONS.
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 : 3
Manufacturer
HOLOGIC, INCCountry of Origin
United States
Authorized Representative
PT. UROGEN ADVANCED SOLUTIONSAR Address
Jl. Musi Nomor 37, RT.012, RW.005, Kelurahan Cideng
Registration Date
Oct 17, 2022
Expiry Date
Sep 30, 2025
Product Type
Diagnostic Radiology Equipment
Digital Breast Tomosynthesis
Electromedic Radiation
Aptimaยฎ HIV-1 Quant Dx Assay
ThinPrep Genesis Processor
ThinPrep Pap Test Preservcyt Solution
ThinPrep Microscope Slides
ThinPrep Arcless Microscope Slides
ThinPrep Non-Gyn Filter
ThinPrep Gyn Filters
ThinPrep 2000 Processor and Accessories
APTIMA HBV Quant Assay Calibrator
ThinPrep 5000 Processor and Accessories
CLARIUS Scanner EC7 HD3
CLARIUS MOBILE HEALTH CORP
CLARIUS Scanner C3 HD3
CLARIUS MOBILE HEALTH CORP
CLARIUS Scanner L15 HD3
CLARIUS MOBILE HEALTH CORP
CLARIUS Scanner C7 HD3
CLARIUS MOBILE HEALTH CORP
CLARIUS L20 HD Ultrasound Scanner
CLARIUS MOBILE HEALTH CORP
CLARIUS PA HD Ultasound Scanner
CLARIUS MOBILE HEALTH
CLARIUS L7 HD Ultasound Scanner
CLARIUS MOBILE HEALTH
CLARIUS EC7 HD Ultasound Scanner
CLARIUS MOBILE HEALTH
CLARIUS C7 HD Ultasound Scanner
CLARIUS MOBILE HEALTH

