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HYPERGLIDE Occlusion Balloon System - Indonesia BPOM Medical Device Registration

HYPERGLIDE Occlusion Balloon System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20504717887. The device is manufactured by MICRO THERAPEUTICS, INC, DBA EV3 NEUROVASCULAR from United States, 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
HYPERGLIDE Occlusion Balloon System
Analysis ID: AKL 20504717887

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. MEDTRONIC INDONESIA

AR Address

Gandaria 8 Office Tower Lantai 36 Unit A, Jl. Sultan Iskandar Muda

Registration Date

May 25, 2022

Expiry Date

Feb 16, 2027

Product Type

Surgical Cardiology Equipment

Vascular clamp.

Non Electromedic Sterile

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