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BOMEDENT iRoot apex (Apex Locators) - Indonesia BPOM Medical Device Registration

BOMEDENT iRoot apex (Apex Locators) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20601420009. The device is manufactured by CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY, CO.,LTD from China, and is classified as Risk Class Kelas Resiko : B. 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 : B
BOMEDENT iRoot apex (Apex Locators)
Analysis ID: AKL 20601420009

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. DENTALITIES GROUP ASIA

AR Address

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

Registration Date

Mar 08, 2024

Expiry Date

Jul 01, 2028

Product Type

Diagnostic Dental Equipment

Root apex locator

Non Electromedic Non Sterile

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