Pure Global

OPIDEX OPA - Indonesia BPOM Medical Device Registration

OPIDEX OPA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20903420175. The device is manufactured by FIRSON HEALTHCARE CO., LTD from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is FIVE ALIGNED DISPOS.

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
OPIDEX OPA
Analysis ID: AKL 20903420175

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Korea

Authorized Representative

FIVE ALIGNED DISPOS

AR Address

Jl. Pulo Sirih Barat Blok M/15, Jaka Setia, Bekasi 17147

Registration Date

Feb 21, 2024

Expiry Date

Mar 03, 2026

Product Type

General Hospital Equipment and Other Individuals

Liquid chemical sterilants/high level disinfectants.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing