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OPTIMA Coil System - Indonesia BPOM Medical Device Registration

OPTIMA Coil System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21003910012. The device is manufactured by BALT USA, LLC from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is MEDIKON MAIN PHARMALAB.

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
OPTIMA Coil System
Analysis ID: AKL 21003910012

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

BALT USA, LLC

Country of Origin

United States

Authorized Representative

MEDIKON MAIN PHARMALAB

AR Address

JLN. RAYA PASAR MINGGU NO 15, RT.001/07

Registration Date

Feb 21, 2024

Expiry Date

Jan 09, 2027

Product Type

Therapeutic Neurology Equipment

Neurovascular embolization device.

Non Electromedic Sterile

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