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ACURATE neo2 Aortic Valve - Indonesia BPOM Medical Device Registration

ACURATE neo2 Aortic Valve is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503320370. The device is manufactured by ACURATE INDUSTRIA E COMERCIO LTDA BHM SITE (BELO HORIZONTE SITE) from Brazil, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. 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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BPOM Registered
Risk Class Kelas Resiko : D
ACURATE neo2 Aortic Valve
Analysis ID: AKL 30503320370

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Brazil

Authorized Representative

PT. BOSTON SCIENTIFIC INDONESIA

AR Address

PRUDENTIAL TOWER, LT. 28, JL. JEND. SUDIRMAN KAV. 79

Registration Date

Jul 29, 2024

Expiry Date

Apr 07, 2028

Product Type

Prosthetic Cardiology Equipment

Prosthesis Percutaneously Delivered Aortic Valve

Non Electromedic Sterile

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