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OPTIMA MR450w 1.5T - Indonesia BPOM Medical Device Registration

OPTIMA MR450w 1.5T is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501819085. The device is manufactured by GE HEALTHCARE MANUFACTURING LLC from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. GE OPERATIONS INDONESIA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : C
OPTIMA MR450w 1.5T
Analysis ID: AKL 21501819085

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. GE OPERATIONS INDONESIA

AR Address

South Quarter Tower B, Lantai 18-19 Jl. R.A. Kartini, Kav. 8 Kel. Cilandak Barat, Kec. Cilandak Jakarta Selataran 12430

Registration Date

Jul 28, 2021

Expiry Date

Jun 21, 2024

Product Type

Diagnostic Radiology Equipment

Magnetic resonance diagnostic device.

Non Radiation Electromedics

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