Identity
- Trade Name
- Gastro+ EUDAMEDGastrolyzer FDA UDI
- Generic Name
- Hydrogen breath analyser FDA UDI
- Device Name
- Gastro+ EUDAMEDThe 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. FDA UDI
- Model / Reference
- Gastrolyzer EUDAMEDGASTRO EUDAMEDGastro+ FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- GASTRO FDA UDI
- Primary DI / UDI-DI
- 05060246860108 EUDAMEDFDA UDI
- Basic UDI-DI
- 506024686GG013X EUDAMED
- Direct Marketing DI
- 05060246860108 EUDAMED
- FDA Product Code
- NRH FDA UDI
- EMDN Code
- Z12159006 EXPIRATED GAS ANALYSERS EUDAMED
- GMDN Term
- Hydrogen breath analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1820 FDA UDI
- Market of Registration
- Hungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Gastro+ by Bedfont Scientific Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506024686GG013X | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bedfont Scientific Ltd
- EUDAMED SRN
- GB-MF-000010889
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 3c1060ca-76bc-4fd1-a789-0d5d06fc1af8 61 fields · synced Jul 12, 2026
- FDA UDI 620d4631-0467-413d-b864-94537d9d29b6 34 fields · synced May 30, 2026