BreathID® Smart System

Test, Urea (breath Or Blood)

Meridian Bioscience Israel Ltd.

The following data is part of a premarket notification filed by Meridian Bioscience Israel Ltd. with the FDA for Breathid® Smart System.

Pre-market Notification Details

Device IDK223185
510k NumberK223185
Device Name:BreathID® Smart System
ClassificationTest, Urea (breath Or Blood)
Applicant Meridian Bioscience Israel Ltd. 4 Ha'Maayan St Modiin,  IL 7177872
ContactRaffi Werner
CorrespondentRaffi Werner
Meridian Bioscience Israel Ltd. 4 Ha'Maayan St Modiin,  IL 7177872
Product CodeMSQ  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-10-12
Decision Date2022-11-10

Trademark Results [BreathID]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BREATHID
BREATHID
90210297 not registered Live/Pending
Exalenz Bioscience Ltd.
2020-09-25
BREATHID
BREATHID
76328796 2864038 Live/Registered
EXALENZ BIOSCIENCE LTD.
2001-10-22

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