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LUTONIX ™ 035 Drug Coated Balloon PTA Catheter - Indonesia BPOM Medical Device Registration

LUTONIX ™ 035 Drug Coated Balloon PTA Catheter is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30505520003. The device is manufactured by C.R. BARD from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. BECTON DICKINSON INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : D
LUTONIX ™ 035 Drug Coated Balloon PTA Catheter
Analysis ID: AKL 30505520003

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

C.R. BARD

Country of Origin

United States

Authorized Representative

PT. BECTON DICKINSON INDONESIA

AR Address

Sampoerna Strategic Square South Tower 20th Floor Jl. Jend. Sudirman Kav 45-46

Registration Date

Jan 13, 2025

Expiry Date

Aug 19, 2029

Product Type

Therapeutic Cardiology Equipment

Drug Eluting Balloon

Non Electromedic Sterile

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