BALL Cal-5Diff A1 - Indonesia BPOM Medical Device Registration
BALL Cal-5Diff A1 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208320880. The device is manufactured by BOULE MEDICAL. from Sweden, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SWELAB 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.
BOULE Cal-5Diff A1
Risk Classification
Product Class
Kelas : 2
Manufacturer
BOULE MEDICAL.Country of Origin
Sweden
Authorized Representative
PT. SWELAB INDONESIAAR Address
Jl. HBR Motik Komplek Kumala Burlian R/14 RT 031 RW.009 Kelurahan Karya Baru Kecamatan Alang-Alang lebar Palembang
Registration Date
Dec 05, 2023
Expiry Date
Oct 18, 2026
Product Type
Hematological Reagents
Calibrator for hemoglobin or hematocrit measurement.
Invitro Diagnostics
SWELAB Lumi L1-Lyse
LUMILAB BOULE Cal-5Diff A1
SWELAB Lumi and Accessories
SWELAB Snow-D Diluent
BOULE Medonic M-series Diluent
MEDONIC M51-D Diluent
BOULE Medonic M-series Lyse
BOULE Con-5Diff A1 Norm
BOULE Medonic M-Series Dualpack, RFID
BOULE Medonic M-Series Diluent, RFID
SWELAB Alfa Plus Standard and Accessories
BOULE MEDICAL, AB
BOULE Con-Diff N
BOULE MEDICAL, AB
BOULE Con-Diff Tri L
BOULE MEDICAL, AB
BALL Cal
BOULE MEDICAL, AB
BOULE Con-5Diff A1 Norm
BOULE MEDICAL.
BALL Con-5Diff A1 Tri
BOULE MEDICAL AB
ECG - Expert
CUSTOM SOFTWARE & ELECTRONICS, S.L.
QUINTUS 5-part Hematology Analyzer and Accessories
BOULE MEDICAL.
SWELAB ALFA Plus Sampler
BOULE MEDICAL.
SWELAB Alfa Plus Cap and Accessories
BOULE MEDICAL.