Pure Global

OVUTEST Digital - Indonesia BPOM Medical Device Registration

OVUTEST Digital is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323020. The device is manufactured by SUGENTECH,INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DANPAC PHARMA.

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
OVUTEST Digital
Analysis ID: AKL 20101323020

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SUGENTECH,INC.

Country of Origin

Korea

Authorized Representative

PT. DANPAC PHARMA

AR Address

Plaza Asia, Lt. 6D, Kav. 59, RT 005/RW 003

Registration Date

Jun 07, 2023

Expiry Date

Mar 03, 2026

Product Type

Clinical Chemistry Test System

Luteinizing hormone test system (strip & midstream)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing