EDAN Digital Diagnostic Ultrasound System - Indonesia BPOM Medical Device Registration
EDAN Digital Diagnostic Ultrasound System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501615334. The device is manufactured by EDAN INSTRUMENTS, INC. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. GLOBAL SYSTECH MEDIKA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
EDAN INSTRUMENTS, INC.Country of Origin
China
Authorized Representative
PT. GLOBAL SYSTECH MEDIKAAR Address
Jl. TB Simatupang No.17 RT.011/002 Kel. Susukan, Kec. Ciracas Jakarta Timur
Registration Date
Jan 07, 2021
Expiry Date
Dec 18, 2023
Product Type
Diagnostic Radiology Equipment
Ultrasonic pulsed doppler imaging system.
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