BIOSYSTEMS Total Bile Acids - Indonesia BPOM Medical Device Registration
BIOSYSTEMS Total Bile Acids is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101420392. The device is manufactured by BIOSYSTEMS S.A. from Spain, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ELGA TAMA.
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
BIOSYSTEMS S.A.Country of Origin
Spain
Authorized Representative
ELGA TAMAAR Address
JL. RASAMALA RAYA NO. 12 D RT. 006 RW. 003 KELURAHAN JATIPULO, KECAMATAN PALMERAH
Registration Date
Mar 10, 2024
Expiry Date
Dec 24, 2025
Product Type
Clinical Chemistry Test System
Cholylglycine test system (kit & cair)
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
BIOSYSTEMS CARBON DIOXIDE (CO2)
BIOSYSTEMS S.A.
BIOSYSTEMS APOLIPOPROTEIN B (APO B)
BIOSYSTEMS S.A.
BIOSYSTEMS SEROLOGY NEGATIVE CONTROL
BIOSYSTEMS S.A.
NEOMEDICA Neo Diluent C
NEOMEDICA D.O.O.
NEOMEDICA Neo U Stain
NEOMEDICA DOO
BIOSYSTEMS Activated Partial Thromboplastin Time (APTT)
BIOSYSTEMS S.A.
BIOSYSTEMS Fibrinogen Clauss
BIOSYSTEMS S.A.
BIOSYSTEMS Cholesterol HDL Direct
BIOSYSTEMS S.A.
BIOSYSTEMS AMMONIA, ETHANOL, CO2 CONTROL I
BIOSYSTEMS S.A.
BIOSYSTEMS Oxalate
BIOSYSTEMS S.A.

