Pure Global

I-SMART 300 Cartridge - Indonesia BPOM Medical Device Registration

I-SMART 300 Cartridge is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101020606. The device is manufactured by I-SENS INC. from Korea, and is classified as Risk Class Kelas Resiko : B. 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
I-SMART 300 Cartridge
Analysis ID: AKL 20101020606

Risk Classification

Kelas Resiko : B

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

Jul 05, 2024

Expiry Date

Apr 05, 2029

Product Type

Clinical Chemistry Test System

Blood gases (P CO 2, P O 2) and blood pH test system (kit & cair)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from I-SENS INC.
Products from the same manufacturer (1 products)