FORTACEDX Cholesterol MR - Indonesia BPOM Medical Device Registration
FORTACEDX Cholesterol MR is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323151. The device is manufactured by LINEAR CHEMICALS, S.L.U from Spain, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FORTACE DIAGNOSTICS 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
LINEAR CHEMICALS, S.L.UCountry of Origin
Spain
Authorized Representative
PT. FORTACE DIAGNOSTICS INDONESIAAR Address
FORTACE DIAGNOSTICS INDONESIA
Registration Date
Jul 11, 2023
Expiry Date
May 26, 2026
Product Type
Clinical Chemistry Test System
Cholesterol (total) test system (kit & cair)
Invitro Diagnostics
GLORY DIAGNOSTICS โ ANTI HCV CASSETTE
FORTACEDX Cholesterol Standard
GLORY DIAGNOSTICS โ CRP LATEX
FORTACEdx Albumin
FORTACEdx LDL-Cholesterol Direct
FORTACEDX Total Protein
FORTACEDX Human Multisera Normal
FORTACEDX Multicalibrator CC/H
FORTACEDX Human Multisera Abnormal
FORTACEDX Alkaline Phosphatase BR
FORTACEDX Cholesterol Standard
LINEAR CHEMICALS, S.L.U
FORTACEDX H380 Hematology Control Set (L-N-H)
DIATRON MI PLC
FORTACEDX H380 Hematology Control (High Level)
DIATRON MI PLC
FORTACEDX H380 Hematology Control (Normal Level)
DIATRON MI PLC
FORTACEDX H380 Hematology Control (Low Level)
DIATRON MI PLC
FORTACEDX H380 Hematology Calibrator
DIATRON MI PLC
FORTACEDX H380 Cleaner
DIATRON MI PLC
FORTACEDX H380 Hypoclean CC
DIATRON MI PLC
FORTACEDX H380 Lyse
DIATRON MI PLC
FORTACEDX H380 Diluent
DIATRON MI PLC

