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TRON FX II Thrombectomy Device - Indonesia BPOM Medical Device Registration

TRON FX II Thrombectomy Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21003026811. The device is manufactured by YOKOWO CO., LTD. TOMIOKA PLANT from Japan, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. QUALTEK CONSULTANT JAKARTA.

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BPOM Registered
Risk Class Kelas Resiko : C
TRON FX II Thrombectomy Device
Analysis ID: AKL 21003026811

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Japan

Authorized Representative

PT. QUALTEK CONSULTANT JAKARTA

AR Address

Icon Business Park Blok K No 6, BSD City, Kab Tangerang, Banten

Registration Date

Oct 14, 2021

Expiry Date

Jul 31, 2025

Product Type

Therapeutic Neurology Equipment

Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment

Non Electromedic Sterile

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