IsoFlow Sheath Fluid - Indonesia BPOM Medical Device Registration
IsoFlow Sheath Fluid is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208320411. The device is manufactured by BECKMAN COULTER, INC from United States, and is classified as Risk Class Kelas Resiko : B. 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
BECKMAN COULTER, INCCountry of Origin
United States
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
Jan 25, 2023
Expiry Date
Jun 01, 2025
Product Type
Hematological Reagents
Blood cell diluents
Invitro Diagnostics
BECKMAN COULTER Access Total ฮฒhCG (5th IS)
BECKMAN COULTER DxU 810c Iris Urine Chemistry Analyzer
BECKMAN COULTER DxU 840m Iris Automated Urine Microscopy Analyzer
BECKMAN COULTER DxU 850m Iris Automated Urine Microscopy Analyzer
BECKMAN COULTER Access Unconjugated Estriol Calibrators
BECKMAN COULTER Access TSH (3rd IS)
BECKMAN COULTER Access Ferritin
BECKMAN COULTER ACCESS 25 (OH) Vitamin D Total
BECKMAN COULTER DxC 500i Clinical Analyzer Access 2 Immunoassay Module and Accessories
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent
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
UNITED IMAGING Medical Linear Accelerator System
SHANGHAI UNITED IMAGING HEALTHCARE CO,. LTD