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FLEXITRON HDR Brachytherapy System - Indonesia BPOM Medical Device Registration

FLEXITRON HDR Brachytherapy System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21502615840. The device is manufactured by NUCLETRON B.V. from Netherlands, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MEDIUM FIRST.

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 : C
FLEXITRON HDR Brachytherapy System
Analysis ID: AKL 21502615840

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

NUCLETRON B.V.

Country of Origin

Netherlands

Authorized Representative

PT. MEDIUM FIRST

AR Address

The Belleza Permata Hijau GP Office Tower Lt. 27, Jl. Letjen Soepeno No. 34

Registration Date

Oct 22, 2023

Expiry Date

Jul 11, 2028

Product Type

Therapeutic Radiology Equipment

Remote controlled radionuclide applicator system.

Electromedic Radiation

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