BRAINLAB Stereotaxic System - Indonesia BPOM Medical Device Registration

BRAINLAB Stereotaxic System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21002410744. The device is manufactured by BRAINLAB AG. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FLUORESCENT ANDHIKA PARAMARTHA.

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BPOM Registered

Risk Class Kelas Resiko : B

BRAINLAB Stereotaxic System

Analysis ID: AKL 21002410744

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

Country of Origin

Germany

Authorized Representative

PT. FLUORESCENT ANDHIKA PARAMARTHA

AR Address

RUKAN GADING BUKIT INDAH BLOK U / 09 RT 008 RW 015 - KOMPLEK GADING BUKIT INDAH - JL. BUKIT INDAH RAYA KELAPA GADING JAKARTA UTARA

Registration Date

Nov 22, 2023

Expiry Date

Jul 03, 2026

Product Type

Surgical Neurology Equipment

Stereotaxic instrument.

Non Radiation Electromedics

DJ Fang

MedTech Regulatory Expert

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