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I-SMART® 30 Pro Cartridge E4 - Indonesia BPOM Medical Device Registration

I-SMART® 30 Pro Cartridge E4 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101126510. The device is manufactured by I-SENS INC. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. DUAL NOBLE LIGHT.

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
I-SMART® 30 Pro Cartridge E4
Analysis ID: AKL 20101126510

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

I-SENS INC.

Country of Origin

Korea

Authorized Representative

PT. DUAL NOBLE LIGHT

AR Address

Ruko Villa Jatibening Toll Blok A no. 2 Jatibening - Bekasi

Registration Date

Aug 08, 2024

Expiry Date

Apr 05, 2028

Product Type

Clinical Chemistry Test System

Multi parameter clinical chemistry test system

Invitro Diagnostics

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