BFTROL Level 2 & 3 - Indonesia BPOM Medical Device Registration
BFTROL Level 2 & 3 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208913997. The device is manufactured by R&D SYSTEMS INC. (BIOTECHNE) from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HORIBA 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
R&D SYSTEMS INC. (BIOTECHNE)Country of Origin
United States
Authorized Representative
PT. HORIBA INDONESIAAR Address
Jl. Jalur Sutera , Blok. 20A, No. 16 - 17, Kel. Kunciran, Kec. Pinang
Registration Date
Nov 13, 2023
Expiry Date
Nov 12, 2028
Product Type
Hematological Reagents
Hematology quality control mixture.
Invitro Diagnostics
ABX Pentra Standard 1
HORIBA ABX SAS, FRANCE
HORIBA Pentra C400 Option ISE and Accessories
HORIBA ABX SAS, FRANCE
ABX Pentra Reference 280 ml
HORIBA ABX SAS, FRANCE
ABX Pentra Etching CP
HORIBA ABX SAS, FRANCE
ABX Pentra ISE Cleaner CP
HORIBA ABX SAS, FRANCE
ABX Pentra LDH IFCC CP
HORIBA ABX SAS, FRANCE
YUMIZEN C Urine Level 2 Control
DIASYS DIAGNOSTIC SYSTEMS GMBH.
HORIBA Pentra C400 and Accessories
HORIBA ABX SAS.
YUMIZEN G CTRL DDi I & II
DIAGON LTD
Yumizen G APTT 4
DIAGON LTD

