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FRAX PRO System - Indonesia BPOM Medical Device Registration

FRAX PRO System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603124673. The device is manufactured by NPA DE MEXICO, S, DE, RL DE CV. from Mexico, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. REGENESIS INDONESIA.

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
FRAX PRO System
Analysis ID: AKL 21603124673

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Mexico

Authorized Representative

PT. REGENESIS INDONESIA

AR Address

Jl. Sultan Iskandar Muda No. 7A & B

Registration Date

Jul 30, 2021

Expiry Date

Jan 11, 2026

Product Type

Surgical Equipment

Laser surgical instrument for use in general and plastic surgery and in dermatology.

Non Radiation Electromedics

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