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BreathID® Hp Lab system

EUDAMEDFDA UDIFDA 510(k)

Class IVD General (EU MDR)

Ref VS01082

by Meridian Bioscience Israel Ltd.

Identity

Trade Name
BreathID® Hp Lab system EUDAMED
BreathID Hp Lab System FDA UDI
Generic Name
Infrared spectrometry breath analyser IVD FDA UDI
Device Name
BreathID® Hp Lab system EUDAMED
The BreathID® Hp Lab 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® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application FDA UDI
Model / Reference
VS01082 EUDAMEDFDA UDI
Description
The BreathID® Hp Lab 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® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application FDA UDI

Identifiers

Primary DI / UDI-DI
07290016923070 EUDAMEDFDA UDI
Basic UDI-DI
B-07290016923070 EUDAMED
510(k) Number
K173777 FDA UDI
K220494 FDA UDI
FDA Product Code
MSQ 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 UDI
Regulation Number
866.3110 FDA UDI
862.2300 FDA UDI
Market of Registration
Italy EUDAMED
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
Height — 10 Inch FDA UDI
Width — 15.7 Inch FDA UDI
Depth — 18 Inch FDA UDI
Weight — 9 Kilogram FDA UDI

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

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/IVDD

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Manufacturer

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

Sources (3)

  • EUDAMED acb798bc-bcfb-4771-80fb-0778e579aa45 61 fields · synced Jul 12, 2026
  • FDA UDI 80d12571-b25c-4a80-b4f2-de8ea16ac346 36 fields · synced May 30, 2026
  • FDA 510(k) K221896 1 fields · synced May 18, 2026