FOKUS Malaria Falcivax Pv/Pf Cassette - Indonesia BPOM Medical Device Registration
FOKUS Malaria Falcivax Pv/Pf Cassette is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220309. The device is manufactured by ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD. from India, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FOCUS 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
Country of Origin
India
Authorized Representative
PT. FOCUS DIAGNOSTIC INDONESIAAR Address
18 Office Park, Tower A, Jl. TB Simatupang No.18 MZ Floor, Unit D1-A/89, Kelurahan Kebagusan
Registration Date
May 25, 2022
Expiry Date
May 25, 2025
Product Type
Serological Reagents
Plasmodium species antigen detection assays
Invitro Diagnostics
FOKUS FDI HM-3 Plus Diluent Hematology Reagent
AEHEALTH LIMITED
FlowClean Cleaning Agent
BECKMAN COULTER, INC.
FOKUS Auto 3-Diff Hematology Analyzer
AEHEALTH LIMITED
AQUIOS Cleaning Agent
BECKMAN COULTER, INC.
FOKUS FDI HM-5 Plus DIFF Lyse Hematology Reagent
AEHEALTH LIMITED
FOCUS Leptospira IgM Cassette
ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.
FOKUS FDI HM-5 Plus Diluent Hematology Reagent
AEHEALTH LIMITED
FOCUS Syphicheck WB device
ZEPHYR BIOMEDICALS - A DIV. OF TULIP DIAGNOSTICS (P) LTD.
FOKUS Love-Gruenwald Laminectomy Rongeur Instrument
CEATEC MEDIZINTECHNIK GMBH & CO. KG.
FOKUS Measuring Instrument Set II
CEATEC MEDIZINTECHNIK GMBH