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ACURATE neo2 Transfemoral Delivery System - Indonesia BPOM Medical Device Registration

ACURATE neo2 Transfemoral Delivery System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503320329. 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 BOSTON SCIENTIFIC 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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Risk Class Kelas Resiko : D
ACURATE neo2 Transfemoral Delivery System
Analysis ID: AKL 30503320329

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Ireland

Authorized Representative

BOSTON SCIENTIFIC INDONESIA

AR Address

Prudential Tower lantai 28 Jl. Jend. Sudirman Kav. 79

Registration Date

Nov 03, 2023

Expiry Date

Apr 07, 2028

Product Type

Prosthetic Cardiology Equipment

Prosthesis Percutaneously Delivered Aortic Valve

Non Electromedic Sterile

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