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CUDA LED Headlight System - Indonesia BPOM Medical Device Registration

CUDA LED Headlight System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11203420073. The device is manufactured by SUNOPTIC TECHNOLOGIES from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. LUMARY BIRUMAS.

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 : A
CUDA LED Headlight System
Analysis ID: AKL 11203420073

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

United States

Authorized Representative

PT. LUMARY BIRUMAS

AR Address

Gd. Menara Palma Lt. 12 Jl. H.R. Rasuna Said Blok X-2, Kav.6 Jakarta 12950

Registration Date

Apr 23, 2024

Expiry Date

Jun 26, 2028

Product Type

Surgical Eye Equipment

Operating headlamp.

Non Electromedic Non Sterile

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