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FUSION COMPACT™ ENT NAVIGATION SYSTEM - Indonesia BPOM Medical Device Registration

FUSION COMPACT™ ENT NAVIGATION SYSTEM is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21002021771. The device is manufactured by MEDTRONIC NAVIGATION, INC 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
FUSION COMPACT™ ENT NAVIGATION SYSTEM
Analysis ID: AKL 21002021771

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, Desa/Kelurahan Kebayoran Lama Utara, Kec. Kebayoran Lama

Registration Date

Feb 01, 2025

Expiry Date

Feb 07, 2028

Product Type

Surgical Neurology Equipment

Stereotaxic instrument.

Non Radiation Electromedics

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