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ERMA ISE Pak (ISE Reagent) - Indonesia BPOM Medical Device Registration

ERMA ISE Pak (ISE Reagent) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221243. The device is manufactured by AGD BIOMEDICALS P LTD from India, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MEDISTA 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
ERMA ISE Pak (ISE Reagent)
Analysis ID: AKL 20101221243

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

India

Authorized Representative

PT. MEDISTA MAIN

AR Address

Jl. Pondok Cibubur No. 133

Registration Date

Nov 02, 2023

Expiry Date

Jul 25, 2028

Product Type

Clinical Chemistry Test System

Multi parameter clinical chemistry test system

Invitro Diagnostics

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