Basic UDI-DI
Eu Mdr
Eu Md Class 1
OpenOR System
Code: 6438435SY0001UH
Devices
1
Certificates
0
Notified Bodies
0
Auth. Representatives
0
Basic Information
- UDI-DI Code
- 6438435SY0001UH
- Issuing Agency
- GS1
- Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Last Updated
- January 18, 2024
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.
Certificate Health
No certificates associated with this Basic UDI-DI.
Associated Devices
This Basic UDI-DI is associated with 1 device.
| Name | Status |
|---|---|
| OpenOR System | On the market |