Pure Global

ImageXplorer - Indonesia BPOM Medical Device Registration

ImageXplorer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305420642. The device is manufactured by MACROARRAY DIAGNOSTICS (MADX) from Austria, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is MRK DIAGNOSTICS.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
ImageXplorer
Analysis ID: AKL 20305420642

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Austria

Authorized Representative

MRK DIAGNOSTICS

AR Address

JL. Merpati Mas I Blok B1 NO.46 Perkantoran Tanjung Mas Raya Tanjung Barat

Registration Date

Dec 13, 2024

Expiry Date

Sep 18, 2026

Product Type

Immunological Test System

Radioallergosorbent (RAST) immunological test system.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from MACROARRAY DIAGNOSTICS (MADX)
Products from the same manufacturer (2 products)