TULSA - PRO System - Indonesia BPOM Medical Device Registration
TULSA - PRO System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20804420010. The device is manufactured by PROFOUND MEDICAL INC. from Canada, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TRANSMEDIC INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
PROFOUND MEDICAL INC.Country of Origin
Canada
Authorized Representative
PT. TRANSMEDIC INDONESIAAR Address
Perkantoran Menara Era Unit G-01 JL.Senen Raya No.135-137 RT 00 RW 00, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Senen, Kel. Senen
Registration Date
Mar 11, 2024
Expiry Date
Nov 25, 2027
Product Type
Gastroenterology-Surgical Urology Equipment
High intensity ultrasound system for prostate tissue ablation
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