BIOSYSTEMS BTS-350 Semiautomatic Analyzer and Accesories - Indonesia BPOM Medical Device Registration
BIOSYSTEMS BTS-350 Semiautomatic Analyzer and Accesories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10102514279. The device is manufactured by BIOSYSTEMS S.A. from Spain, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. MULTISERA INDOSA.
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 : 1
Manufacturer
BIOSYSTEMS S.A.Country of Origin
Spain
Authorized Representative
PT. MULTISERA INDOSAAR Address
JL. JEND. SUDIRMAN NO. 689 RT/RW : 21/07
Registration Date
Jun 19, 2021
Expiry Date
Jul 13, 2025
Product Type
Clinical Laboratory Equipment
Colorimeter, photometer, or spectrophotometer for clinical use.
Invitro Diagnostics
BIOSYSTEMS RHEUMATOID FACTORS (RF) STANDARD
BIOSYSTEMS APOLIPOPROTEIN B (APO B)
BIOSYSTEMS CARBON DIOXIDE (CO2)
BIOSYSTEMS Homocysteine Standards
BIOSYSTEMS SEROLOGY NEGATIVE CONTROL
BIOSYSTEMS FIBRINOGEN CONTROL PLASMA
BIOSYSTEMS APOLIPOPROTEIN B (APO B) STANDARD
BIOSYSTEMS HOMOCYSTEINE CONTROL II
BIOSYSTEMS CK-MB CONTROL SERUM II
BIOSYSTEMS HOMOCYSTEINE CONTROL I
DIESTRO ISE Calibrating KIT
JS MEDICINA ELECTRONICA S.R.L.
DIESTRO Calibrating Solutions Pack
JS MEDICINA ELECTRóNICA S.R.L.
ALIFAX Roller 20 LC
ALIFAX S.R.L.
ALIFAX Latex Calibrator
ALIFAX S.R.L.
NODFORD HbA1c Test Kit (Dry Fluorescence Immunoassay)
SHENZHEN NODFORD INDUSTRIAL CO., LTD
DIESTRO 103AP V4 Semiautomatic Plus Electrolyte Analyzer 5P
JS MEDICINA ELECTRONICA S.R.L
AMOS SCIENTIFIC Thermal Console
AMOS SCIENTIFIC PTY., LTD.
AMOS SCIENTIFIC Fully Automatic Rotary Microtome
AMOS SCIENTIFIC PTY. LTD.
AMOS SCIENTIFIC Manual Rotary Microtome
AMOS SCIENTIFIC PTY LTD.
AMOS SCIENTIFIC TEC 2602 Slide Dryer
AMOS SCIENTIFIC PTY. LTD