Eu Mdr Eu Md Class 1 On The Market

OpenOR System

The OpenOR System is intended for an integrated operating room control system for non-medical and class I medical devices. OpenOR System is used for transmitting information and to control non-medical and medical devices in an operating room. The OpenOR System does not have medical purpose. The OpenOR System is not intended for diagnosis and to control MDR Class Is, Im, IIa, IIb and III medical devices. The OpenOR System must be used in an operating room environment by trained healthcare professionals only.

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06438435400043
Basic UDI-DI Code
6438435SY0001UH
Reference
200040004
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

The OpenOR System is intended for an integrated operating room control system for non-medical and class I medical devices. OpenOR system is used for transmitting information and to control non-medical and medical devices in an operating room. The OpenOR System does not have medical purpose. The OpenOR System is not intended for diagnosis and to control MDR Class Is, Im, IIa, IIb and III medical devices. The OpenOR System must be used in an operating room environment by trained healthcare professionals only.

Medical Purpose

The OpenOR System is intended for an integrated operating room control system for non-medical and class I medical devices. OpenOR System is used for transmitting information and to control non-medical and medical devices in an operating room. The OpenOR System does not have medical purpose. The OpenOR System is not intended for diagnosis and to control MDR Class Is, Im, IIa, IIb and III medical devices. The OpenOR System must be used in an operating room environment by trained healthcare professionals only.

CND Nomenclature Codes

Code Description
Y241299 AMBIENT CONTROL SYSTEMS - OTHER

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