Identity
- Trade Name
- GastroGenius EUDAMEDGastrolyzer FDA UDI
- Generic Name
- Multiple gas breath analyser FDA UDI
- Device Name
- GastroCHECK EUDAMEDThe GastroGENIUS® is a portable desktop monitor which measures hydrogen (H2), methane (CH4) and oxygen (O2) leaves in expired breath samples in response to appropriate substrates. It is intended to be for multi-patient use on children and adults and used by healthcare professionals primarily in a hospital, or physician's surgery. The expired breath can be delivered direct to the monitor for immediate analysis via a mouthpiece or a sample can be taken remotely via a breath-bag for subsequent analysis. The GastroGENIUS® will be used by a single patient at a time but will interface with a PC to allow a multi-patient sampling protocol to be performed. The GastroGENIUS® can be used as an aid to diagnose the following disorders: Carbohydrate breakdown deficiency Carbohydrate malabsorption Lactose intolerance Bacterial overgrowth Determination of time of passage through gut Specific diagnosis is not possible with this device; further specific testing would need to be carried out to diagnose a patient's condition. FDA UDI
- Model / Reference
- Gastrolyzer EUDAMEDLMTCH4 EUDAMEDGastroGENIUS FDA UDI
- Description
- The GastroGENIUS® is a portable desktop monitor which measures hydrogen (H2), methane (CH4) and oxygen (O2) leaves in expired breath samples in response to appropriate substrates. It is intended to be for multi-patient use on children and adults and used by healthcare professionals primarily in a hospital, or physician's surgery. The expired breath can be delivered direct to the monitor for immediate analysis via a mouthpiece or a sample can be taken remotely via a breath-bag for subsequent analysis. The GastroGENIUS® will be used by a single patient at a time but will interface with a PC to allow a multi-patient sampling protocol to be performed. The GastroGENIUS® can be used as an aid to diagnose the following disorders: Carbohydrate breakdown deficiency Carbohydrate malabsorption Lactose intolerance Bacterial overgrowth Determination of time of passage through gut Specific diagnosis is not possible with this device; further specific testing would need to be carried out to diagnose a patient's condition. FDA UDI
Identifiers
- Catalog Number
- LMTCH4 FDA UDI
- Primary DI / UDI-DI
- 05060246860399 EUDAMEDFDA UDI
- Basic UDI-DI
- 506024686GC013B EUDAMED
- Direct Marketing DI
- 05060246860399 EUDAMED
- FDA Product Code
- NRH FDA UDI
- EMDN Code
- Z12159006 EXPIRATED GAS ANALYSERS EUDAMED
- GMDN Term
- Multiple gas breath analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1820 FDA UDI
- Market of Registration
- Netherlands 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
GastroGenius 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 | 506024686GC013B | 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 0c038cf0-d271-465c-a2b4-05d4e9ab832e 61 fields · synced Jun 19, 2026
- FDA UDI cfe77c22-7009-44e6-b6b0-4c58845c33b7 34 fields · synced May 30, 2026