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IRIDEX TX Cell with IQ 577 System - Indonesia BPOM Medical Device Registration

IRIDEX TX Cell with IQ 577 System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21203320305. The device is manufactured by IRIDEX CORPORATION from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TOPSINDO MEGAH UTAMA.

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BPOM Registered
Risk Class Kelas Resiko : C
IRIDEX TX Cell with IQ 577 System
Analysis ID: AKL 21203320305

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

IRIDEX CORPORATION

Country of Origin

United States

Authorized Representative

PT. TOPSINDO MEGAH UTAMA

AR Address

Jl. P. Jayakarta No. 55 Gedung Baja Tower C Lt. 3 Unit C 03-01

Registration Date

Feb 11, 2025

Expiry Date

Dec 15, 2029

Product Type

Surgical Eye Equipment

Ophthalmic laser.

Non Radiation Electromedics

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