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GEMSS Mobile Surgical Fluoroscopic X-Ray System - Indonesia BPOM Medical Device Registration

GEMSS Mobile Surgical Fluoroscopic X-Ray System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501916425. The device is manufactured by GEMSS MEDICAL SYSTEMS CO., LTD from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. GEMSS MEDICAL 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
GEMSS Mobile Surgical Fluoroscopic X-Ray System
Analysis ID: AKL 21501916425

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Korea

Authorized Representative

PT. GEMSS MEDICAL INDONESIA

AR Address

Graha Mandiri Lantai 31, Jalan Imam Bonjol no 61

Registration Date

Oct 07, 2019

Expiry Date

May 22, 2024

Product Type

Diagnostic Radiology Equipment

Image-intensified fluoroscopic x-ray system.

Electromedic Radiation

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