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DRAGONFLY™ Transcatheter Mitral Valve Repair System and Accessories - Indonesia BPOM Medical Device Registration

DRAGONFLY™ Transcatheter Mitral Valve Repair System and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30503520014. The device is manufactured by HANGZHOU VALGEN MEDTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. PURE SOUTHEAST ASIA INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : D
DRAGONFLY™ Transcatheter Mitral Valve Repair System and Accessories
Analysis ID: AKL 30503520014

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

China

Authorized Representative

PT. PURE SOUTHEAST ASIA INDONESIA

AR Address

Equity Tower, 26th Floor H, Kav 52-53, Jl. Jenderal Sudirman

Registration Date

Feb 06, 2025

Expiry Date

Jun 11, 2029

Product Type

Prosthetic Cardiology Equipment

Cardiology Clip

Non Electromedic Sterile

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