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The OZAKI AVNeoTM Sizer System - Indonesia BPOM Medical Device Registration

The OZAKI AVNeoTM Sizer System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20503220052. The device is manufactured by DUMBBELL TECHNOLOGIES, INC from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is GEM OF GRACE VIBRASA.

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 : B
The OZAKI AVNeoTM Sizer System
Analysis ID: AKL 20503220052

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

GEM OF GRACE VIBRASA

AR Address

Perkantoran CBD Ciledug Jl. Hos Cokroaminoto No. 93 Ruko perkantoran CBD Ciledug Blok A3 No. 28

Registration Date

Jun 24, 2022

Expiry Date

Mar 02, 2027

Product Type

Prosthetic Cardiology Equipment

Prosthetic heart valve sizer.

Non Electromedic Sterile

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