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 ID | K223185 |
| 510k Number | K223185 |
| Device Name: | BreathID® Smart System |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | Meridian Bioscience Israel Ltd. 4 Ha'Maayan St Modiin, IL 7177872 |
| Contact | Raffi Werner |
| Correspondent | Raffi Werner Meridian Bioscience Israel Ltd. 4 Ha'Maayan St Modiin, IL 7177872 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-12 |
| Decision Date | 2022-11-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016923353 | K223185 | 000 |
| 07290016923346 | K223185 | 000 |
Trademark Results [BreathID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BREATHID 90210297 not registered Live/Pending |
Exalenz Bioscience Ltd. 2020-09-25 |
 BREATHID 76328796 2864038 Live/Registered |
EXALENZ BIOSCIENCE LTD. 2001-10-22 |
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