OPX001

Organization name

Unident AB

SRN

SE-MF-000004887

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

Primary placement in Sweden; available across 4 countries total.

Trade name

not provided

UDI-DI code

07350118640012

Basic UDI-DI

735011864OPXK8

Reference / catalog number

OPX001

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Onepix® is a software package developed by Unident AB for use in acquiring, displaying, and manually manage digital dental x-ray and video images. It provides a user interface so that the operator may acquire images such as digital x-ray sensors and dental video cameras. The computer which runs the Onepix® software serves as the tool through which patient information is entered, image acquisition is initiated, and acquired images are viewed, managed, stored, and retrieved. Onepix is intended to be used by dental health professionals. This includes dentists, dental nurses, dental hygienists and/or dental radiologists. The intended patient population does not interact with the device at any point.

Additional information URL

https://onepix.app/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z110603PICTURE ARCHIVING AND COMMUNICATION SYSTEMS