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MEDTRONIC HawkOne™ Directional Atherectomy System - Indonesia BPOM Medical Device Registration

MEDTRONIC HawkOne™ Directional Atherectomy System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20504916913. The device is manufactured by MEDTRONIC from Ireland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MEDTRONIC INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : B
MEDTRONIC HawkOne™ Directional Atherectomy System
Analysis ID: AKL 20504916913

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

MEDTRONIC

Country of Origin

Ireland

Authorized Representative

PT. MEDTRONIC INDONESIA

AR Address

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda, Desa/Kelurahan Kebayoran Lama Utara, Kec. Kebayoran Lama

Registration Date

Aug 15, 2023

Expiry Date

Feb 16, 2027

Product Type

Surgical Cardiology Equipment

Intraluminal artery stripper.

Non Electromedic Sterile

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