Data / Medical devices / Israel / Meridian Bioscience Israel Ltd.
Meridian Bioscience Israel Ltd.: FDA-registered device maker in Modiin Central, Israel, 7 510(k) clearances
Meridian Bioscience Israel Ltd. is registered with the FDA (registration 3005772418) in Modiin Central, Israel. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 19, 2022. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005772418
- Address
- 4 HaMaayan St, Modiin Central, Israel, 7177872
- Owner or operator
- Meridian Bioscience Israel Ltd. (9088923)
- Roles
- Manufacturer
- First device listed
- October 11, 2017
- Registered through
- 2027
- Brand names listed
- BreathID Hp Lab System, BreathID Hp Lab System, BreathID Smart System, BreathID Hp System, BreathID Smart System, BreathID® Smart System, Breathid Hp System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Manufacturer | accessdata.fda.gov |
| Test, Urea (Breath Or Blood) | MSQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2022 | K221896 | BreathID Hp System | MSQ | Substantially Equivalent | Meridian Bioscience Israel , Ltd. | accessdata.fda.gov |
| November 10, 2022 | K223185 | BreathID® Smart System | MSQ | Substantially Equivalent | Meridian Bioscience Israel , Ltd. | accessdata.fda.gov |
| June 23, 2022 | K220494 | BreathID Hp Lab System, BreathID Smart System | MSQ | Substantially Equivalent | Meridian Bioscience Israel , Ltd. | accessdata.fda.gov |
| February 6, 2020 | K193610 | BreathID Smart System | MSQ | Substantially Equivalent | Exalenz Bioscience , Ltd. | accessdata.fda.gov |
| March 8, 2018 | K173777 | BreathID Hp Lab System | MSQ | Substantially Equivalent | Exalenz Bioscience , Ltd. | accessdata.fda.gov |
| March 8, 2018 | K173772 | BreathID Hp System | MSQ | Substantially Equivalent | Exalenz Bioscience , Ltd. | accessdata.fda.gov |
| October 31, 2016 | K162150 | BreathID Hp Lab System | MSQ | Substantially Equivalent | Exalenz Bioscience , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 7, 2011 | 59891 | Not yet classified | Terminated | IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 1980 | The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted). | accessdata.fda.gov |
Compare with other makers
Updated December 19, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.