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FGM Orthocem - Indonesia BPOM Medical Device Registration

FGM Orthocem is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20602910370. 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.

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BPOM Registered
Risk Class Kelas Resiko : B
FGM Orthocem
Analysis ID: AKL 20602910370

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 08, 2020

Expiry Date

Dec 08, 2025

Product Type

Prosthetic Dental Equipment

Bracket adhesive resin and tooth conditioner.

Non Electromedic Non Sterile

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