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ONYX™ Liquid Embolic System (LES) - Indonesia BPOM Medical Device Registration

ONYX™ Liquid Embolic System (LES) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31003814930. The device is manufactured by MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is MEDTRONIC INDONESIA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : D
ONYX™ Liquid Embolic System (LES)
Analysis ID: AKL 31003814930

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

United States

Authorized Representative

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

Mar 24, 2024

Expiry Date

Feb 20, 2029

Product Type

Therapeutic Neurology Equipment

Neurovascular embolization device.

Non Electromedic Sterile

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