Pure Global

ESSENTIO™ MRI EL DR Pacemaker - Indonesia BPOM Medical Device Registration

ESSENTIO™ MRI EL DR Pacemaker is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503220122. The device is manufactured by BOSTON SCIENTIFIC LIMITED from Ireland, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. TRANSMEDIC INDONESIA.

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 : D
ESSENTIO™ MRI EL DR Pacemaker
Analysis ID: AKL 30503220122

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Ireland

Authorized Representative

PT. TRANSMEDIC INDONESIA

AR Address

Perkantoran Menara Era Unit G-01 JL.Senen Raya No.135-137 RT 00 RW 00, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Senen, Kel. Senen

Registration Date

Aug 19, 2024

Expiry Date

Aug 01, 2027

Product Type

Prosthetic Cardiology Equipment

Implantable pacemaker pulse generator.

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing