DynamX Sprint Sirolimus Eluting BTK Bioadaptor System - Indonesia BPOM Medical Device Registration

DynamX Sprint Sirolimus Eluting BTK Bioadaptor System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503220047. The device is manufactured by ELIXIR MEDICAL CORPORATION from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is TRITRA PRIMA INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : D

DynamX Sprint Sirolimus Eluting BTK Bioadaptor System

Analysis ID: AKL 30503220047

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

ELIXIR MEDICAL CORPORATION

Country of Origin

United States

Authorized Representative

TRITRA PRIMA INDONESIA

AR Address

Taman Sari Persada Blok F-1 Nomor 10

Registration Date

Jun 10, 2022

Expiry Date

Aug 24, 2026

Product Type

Prosthetic Cardiology Equipment

Drug eluting stent

Non Electromedic Sterile

DJ Fang

MedTech Regulatory Expert

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