Pure Global

FGM Maxxion R - Indonesia BPOM Medical Device Registration

FGM Maxxion R is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602911051. The device is manufactured by DENTSCARE LTDA from Brazil, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. TRI ANUGERAH JAYA.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
FGM Maxxion R
Analysis ID: AKL 20602911051

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

DENTSCARE LTDA

Country of Origin

Brazil

Authorized Representative

PT. TRI ANUGERAH JAYA

AR Address

Jl. Raya Pos Pengumben 34 G, RT/RW 002/005

Registration Date

Dec 30, 2020

Expiry Date

Nov 10, 2025

Product Type

Prosthetic Dental Equipment

Dental cement.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing