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SOPIX2 Digital X-ray System - Indonesia BPOM Medical Device Registration

SOPIX2 Digital X-ray System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20601814824. The device is manufactured by PUFF from France, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. DENTALITIES GROUP ASIA.

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
SOPIX2 Digital X-ray System
Analysis ID: AKL 20601814824

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

PUFF

Country of Origin

France

Authorized Representative

PT. DENTALITIES GROUP ASIA

AR Address

Graha Samastya Jl. Alaydrus No. 27 D RT 017 RW 003

Registration Date

Mar 15, 2023

Expiry Date

Dec 02, 2027

Product Type

Diagnostic Dental Equipment

Intraoral source x-ray system.

Non Radiation Electromedics

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