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SOUNDSTAR 3D Diagnostic Ultrasound Catheter - Indonesia BPOM Medical Device Registration

SOUNDSTAR 3D Diagnostic Ultrasound Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501901614. The device is manufactured by SIEMENS HEALTHINEERS LTD. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. JOHNSON & JOHNSON NEW ZEALAND.

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
SOUNDSTAR 3D Diagnostic Ultrasound Catheter
Analysis ID: AKL 20501901614

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Korea

Authorized Representative

PT. JOHNSON & JOHNSON NEW ZEALAND

AR Address

K-Link Tower Lt. 12, Jln. Jend. Gatot Subroto Kav. 59 A

Registration Date

Jul 09, 2022

Expiry Date

Apr 19, 2027

Product Type

Diagnostic Cardiology Equipment

Diagnostic intravascular catheter.

Non Electromedic Sterile

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