FILMARRAY Torch and accessories - Indonesia BPOM Medical Device Registration
FILMARRAY Torch and accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102912977. The device is manufactured by BIOFIRE DIAGNOSTICS, LLC from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.
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
BIOFIRE DIAGNOSTICS, LLCCountry of Origin
United States
Authorized Representative
PT. ENSEVAL MEDIKA PRIMAAR Address
JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG
Registration Date
Dec 26, 2024
Expiry Date
Dec 31, 2027
Product Type
Clinical Laboratory Equipment
Instrumentation for clinical multiplex test systems.
Invitro Diagnostics
BIOFIRE Blood Culture Identification 2 (BCID2) Panel
BioFire Respiratory Panel 2.1 plus (RP2.1plus)
FILMARRAY Meningitis/Encephalitis (ME) Panel
FILMARRAY Pneumonia Panel Plus
FilmArray Gastrointestinal (GI) Panel
BioFire Joint Infection (JI) Panel
MEDRAD Salient Contrast Injector Wireless
PLEXUS MANUFACTURING SDN. BHD. (HILLSIDE)
MEDRAD Salient Contrast Injector Non-Wireless
PLEXUS MANUFACTURING SDN. BHD. (HILLSIDE)
HOKAPI™ CUVETTE
SUZHOU HOKAPI BIOMEDICAL ENGINEERING CO., LTD
DENSICHECK Plus Instrument for VITEK 2 System and Accessories
BIOMERIEUX INC.
VITEK MS System and Accessories
KRATOS ANALYTICAL LTD.
BIOMERIEUX Mycoline
AIDIAN
BIOMERIEUX Uriline
AIDIAN
BacT/ALERT VIRTUO Microbial Detection System and Accessories
BIOMERIEUX INC. (MISSOURI)
Bact/Alert 3D 240
BIOMERIEUX INC. (Missouri)
MEDRAD Salient Contrast Injector Single (Basic and with Wireless RCU)
IMAXEON PTY., LTD.