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Gastrolyzer
BEDFONT SCIENTIFIC LIMITED · Model Gastro+ · UDI-DI 05060246860108
4
510(k) clearances
0
Adverse events
3
Recalls
12
Facilities
Description
The Gastro+™ Gastrolyzer® product is a breath Hydrogen monitor used to measure hydrogen levels in expired breath. It is intended for multi-patient use by healthcare professionals in a clinical environment.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.