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INTUITION Steerable Guidewire Hydro-Track - Indonesia BPOM Medical Device Registration

INTUITION Steerable Guidewire Hydro-Track is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501511823. The device is manufactured by CEA GLOBAL DOMINICANA S.R.L from Dominican, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MEDTRONIC 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.

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BPOM Registered
Risk Class Kelas Resiko : C
INTUITION Steerable Guidewire Hydro-Track
Analysis ID: AKL 20501511823

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Dominican

Authorized Representative

PT. MEDTRONIC INDONESIA

AR Address

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda, Desa/Kelurahan Kebayoran Lama Utara, Kec. Kebayoran Lama

Registration Date

Sep 12, 2023

Expiry Date

Feb 07, 2028

Product Type

Diagnostic Cardiology Equipment

Catheter guide wire.

Non Electromedic Sterile

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