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FLEXCATH ADVANCE™ - Indonesia BPOM Medical Device Registration

FLEXCATH ADVANCE™ is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501125390. The device is manufactured by MEDTRONIC CRYOCATH LP from Canada, 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
FLEXCATH ADVANCE™
Analysis ID: AKL 20501125390

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Canada

Authorized Representative

PT. MEDTRONIC INDONESIA

AR Address

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda

Registration Date

Sep 01, 2021

Expiry Date

Jan 13, 2026

Product Type

Diagnostic Cardiology Equipment

Steerable catheter.

Non Electromedic Sterile

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