ECG - Expert - Indonesia BPOM Medical Device Registration
ECG - Expert is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20502320633. The device is manufactured by CUSTOM SOFTWARE & ELECTRONICS, S.L. from Spain, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SWELAB INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
CUSTOM SOFTWARE & ELECTRONICS, S.L.Country of Origin
Spain
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
May 16, 2023
Expiry Date
Nov 03, 2027
Product Type
Monitoring Cardiology Equipment
Electrocardiograph.
Non Radiation Electromedics
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 Cal-5Diff A1
BOULE MEDICAL.
BALL Con-5Diff A1 Tri
BOULE MEDICAL AB
QUINTUS 5-part Hematology Analyzer and Accessories
BOULE MEDICAL.
SWELAB Alfa Plus Cap and Accessories
BOULE MEDICAL.
SWELAB ALFA Plus Sampler
BOULE MEDICAL.