Pure Global

D-HEART Portable ECG - Indonesia BPOM Medical Device Registration

D-HEART Portable ECG is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20502917043. The device is manufactured by D-HEART S.R.L from Italy, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is MEDIKON MAIN PHARMALAB.

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
D-HEART Portable ECG
Analysis ID: AKL 20502917043

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

D-HEART S.R.L

Country of Origin

Italy

Authorized Representative

MEDIKON MAIN PHARMALAB

AR Address

JLN. RAYA PASAR MINGGU NO 15 , RT.001/07

Registration Date

Jan 24, 2022

Expiry Date

Dec 31, 2023

Product Type

Monitoring Cardiology Equipment

Electrocardiograph.

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing