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SURESMILE Software - Indonesia BPOM Medical Device Registration

SURESMILE Software is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20604320242. The device is manufactured by ORAMETRIX from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is DENTSPLY SIRONA 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 : B
SURESMILE Software
Analysis ID: AKL 20604320242

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ORAMETRIX

Country of Origin

United States

Authorized Representative

DENTSPLY SIRONA INDONESIA

AR Address

Gedung Tempo Scan Tower, Lantai 28, Jl. H.R. Rasuna Said Kav. 3-4

Registration Date

Nov 02, 2023

Expiry Date

Apr 07, 2028

Product Type

Therapeutic Dental Equipment

Orthodontic plastic bracket.

Non Electromedic Non Sterile

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