SOPHI System - Indonesia BPOM Medical Device Registration
SOPHI System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21203023451. The device is manufactured by THIS AG from Switzerland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. KHASANAH ALKESINDO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
THIS AGCountry of Origin
Switzerland
Authorized Representative
PT. KHASANAH ALKESINDOAR Address
Jl. Prof. Dr. Soepomo SH, No.178 A Royal Palace B 39
Registration Date
Jan 31, 2022
Expiry Date
Mar 02, 2025
Product Type
Surgical Eye Equipment
Phacofragmentation system.
Non Radiation Electromedics
PRECIZON GO
OPHTEC B.V
FOCUS 8/0 PGA
AUROLAB
FOCUS 10/0 Nylon
AUROLAB
ARTISAN Myopia
OPHTEC B.V.
ARTISAN Aphakia
OPHTEC B.V.
OPHTEC Enclavation Needle
OPHTEC B.V.
ARTISAN Toric
OPHTEC B.V.
ARTIFLEX Toric
OPHTEC B.V.
ARTIFLEX Myopia
OPHTEC B.V.
CATAGEL Plus Sodium Hyaluronate Ophthalmic Solution - 1.8%w/v
OPHTHALMIC TECHNOLOGY