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Prime365 - Operating room device management system

Access comprehensive regulatory information for Prime365 - Operating room device management system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Wilhelm Integrated Solutions, manufactured by caresyntax GmbH in Germany. The device registration started on January 14, 2021.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class I
Class I
Prime365 - Operating room device management system
Australia TGA ARTG Registered Device
Good Name: Wilhelm Integrated Solutions - Prime365 - Operating room device management system
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Intended Purpose

PRIME365 is an integration system comprised of a user interface and a routing system. The user interface can either be an in-wall or surface mounted console unit or a Docupoint table or desk mounted unit. The routing system is a fiber optic based IP system with an equipment rack located in a space outside of the procedure area and medical grade endpoints (Encoders, Decoders, and Display) located inside of the procedure area.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
January 14, 2021
Effective Date
January 14, 2021
Manufacturer
Country
Germany
Address
Kaltes Feld 16, Heinsdorfergrund, 08468