Eu Mdr Eu Md Class 1 On The Market 🇺🇸 United States

LIGHT SOURCES

Luminous Global LLC · 🇺🇸 United States
Devices (same UDI-DI)
2
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
00860010307601
Basic UDI-DI Code
08600103076_PLB_Q5
Reference
0860010307601
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
Luminous Global LLC

Additional Description

The device (Luminous, Luminous Pro-Series) is used as an adjunctive to other clinical diagnostic screening procedures like mammography, clinical breast examination, self-breast examination for the early detection of breast abnormalities or diseases or cancer or other conditions. The use of the device is not intended to replace the mammography, clinical breast examination or self-breast examination for breast screening. It is not a sole diagnostic screening device. It is not a diagnostic device. It is intended for adjunctive diagnostic screening

CND Nomenclature Codes

Code Description
Z129004 LIGHT SOURCES

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The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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