BALL Cal - Indonesia BPOM Medical Device Registration
BALL Cal is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208320921. The device is manufactured by BOULE MEDICAL, AB from Sweden, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SWELAB INDONESIA.
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BOULE Cal
Risk Classification
Product Class
Kelas : 2
Manufacturer
BOULE MEDICAL, ABCountry of Origin
Sweden
Authorized Representative
PT. SWELAB INDONESIAAR Address
HBR Motik Komplek Taman Kumala Burlian Blok R/14
Registration Date
Dec 29, 2023
Expiry Date
Oct 18, 2026
Product Type
Hematological Reagents
Calibrator for hemoglobin or hematocrit measurement.
Invitro Diagnostics
SWELAB Alfa Plus Standard and Accessories
BOULE MEDICAL, AB
BOULE Con-Diff N
BOULE MEDICAL, AB
BOULE Con-Diff Tri L
BOULE MEDICAL, AB
BOULE Con-5Diff A1 Norm
BOULE MEDICAL.
BALL Cal-5Diff A1
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 Cap and Accessories
BOULE MEDICAL.
SWELAB ALFA Plus Sampler
BOULE MEDICAL.