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HEART GUARDIAN HR-501 - Indonesia BPOM Medical Device Registration

HEART GUARDIAN HR-501 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505320310. The device is manufactured by RADIANQBIO CO., LTD., KOREA from Korea, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. PERMANA PUTRA MANDIRI.

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 : D
HEART GUARDIAN HR-501
Analysis ID: AKL 30505320310

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Korea

Authorized Representative

PT. PERMANA PUTRA MANDIRI

AR Address

Jl. Taman Mini Indonesia Indah Pintu 2 atas No.43

Registration Date

Nov 18, 2023

Expiry Date

Oct 04, 2028

Product Type

Therapeutic Cardiology Equipment

Automated external defibrillator.

Non Radiation Electromedics

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