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ELITE InGenius - Indonesia BPOM Medical Device Registration

ELITE InGenius is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304127969. The device is manufactured by ELITECHGROUP S.P.A. from Italy, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. RAFA TOPAZ MAIN.

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
ELITE InGenius
Analysis ID: AKL 20304127969

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Italy

Authorized Representative

PT. RAFA TOPAZ MAIN

AR Address

Taman Buaran Indah I Blok U No. 242 Jl. Radin Inten II, Klender, Jakarta Timur

Registration Date

Jun 09, 2023

Expiry Date

Dec 31, 2026

Product Type

Immunology Laboratory Equipment and Reagents

RNA Preanalytical Systems.

Invitro Diagnostics

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DJ Fang

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