← Back to catalogue

BreathID® Smart

EUDAMEDFDA 510(k)FDA UDI

Class IVD General (EU MDR)

Ref VS07000510(k) K223185

by Meridian Bioscience Israel Ltd.

Identity

Trade Name
BreathID® Smart EUDAMED
BreathID Smart System FDA UDI
Generic Name
Infrared spectrometry breath analyser IVD FDA UDI
Device Name
BreathID® Smart EUDAMED
The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device. FDA UDI
Model / Reference
VS07000 EUDAMEDFDA UDI
Description
The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device. FDA UDI

Identifiers

Primary DI / UDI-DI
07290016923223 EUDAMEDFDA UDI
Basic UDI-DI
B-07290016923223 EUDAMED
510(k) Number
K223185 FDA 510(k)FDA UDI
K193610 FDA UDI
K220494 FDA UDI
FDA Product Code
MSQ FDA 510(k)FDA UDI
JJQ FDA UDI
EMDN Code
W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
GMDN Term
Infrared spectrometry breath analyser IVD FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 866.3110 FDA 510(k)
Regulation Number
866.3110 FDA 510(k)FDA UDI
862.2300 FDA UDI
Market of Registration
Italy EUDAMED
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 16 Inch FDA UDI
Width — 15 Inch FDA UDI
Depth — 22 Inch FDA UDI
Weight — 15 Kilogram FDA UDI

BreathID® Smart by Meridian Bioscience Israel Ltd. — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k), FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Meridian Bioscience Israel Ltd.
EUDAMED SRN
IL-MF-000034713
FDA Applicant
Meridian Bioscience Israel , Ltd.
Authorised Representative
Donawa Lifescience Consulting Srl IT-AR-000007785

Sources (3)

  • EUDAMED e64a40dc-c452-42ca-b884-dcd18bac87bb 85 fields · synced Jun 18, 2026
  • FDA 510(k) K223185 24 fields · synced May 18, 2026
  • FDA UDI ada64117-c04f-4dcd-991d-83fb07a109f1 36 fields · synced May 27, 2026