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GeneXpert Dx Instrument System GX-IV - Indonesia BPOM Medical Device Registration

GeneXpert Dx Instrument System GX-IV is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304520002. The device is manufactured by SANMINA SCI SYSTEMS SDN BHD from Malaysia, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MEDQUEST JAYA GLOBAL.

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
GeneXpert Dx Instrument System GX-IV
Analysis ID: AKL 20304520002

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Malaysia

Authorized Representative

PT. MEDQUEST JAYA GLOBAL

AR Address

MENARA SALEMBA LT.6 ZONE 1, Jalan SALEMBA RAYA KAV.5-5A

Registration Date

Jan 10, 2025

Expiry Date

Dec 31, 2025

Product Type

Immunology Laboratory Equipment and Reagents

RNA Preanalytical Systems.

Invitro Diagnostics

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