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Gastrolyzer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GASTROCHECK UKModel Gastrolyzer
Identity
- Trade Name
- Gastrolyzer EUDAMEDFDA UDI
- Generic Name
- Ambient gas analyser FDA UDI
- Device Name
- GastroCHECK EUDAMEDMeasurement of Hydrogen, Methane and Oxygen levels in the exhaled breath. FDA UDI
- Model / Reference
- Gastrolyzer EUDAMEDGASTROCHECK UK EUDAMEDGastroCHECK FDA UDI
- Description
- Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath. FDA UDI
Identifiers
- Catalog Number
- GASTROCHECK FDA UDI
- Primary DI / UDI-DI
- 05060246860368 EUDAMEDFDA UDI
- Basic UDI-DI
- 506024686GC013B EUDAMED
- Direct Marketing DI
- 05060246860368 EUDAMED
- FDA Product Code
- LXG FDA UDI
- EMDN Code
- Z12159006 EXPIRATED GAS ANALYSERS EUDAMED
- GMDN Term
- Ambient gas analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Slovakia 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Gastrolyzer 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 0a79a534-c830-4192-b1af-bbb6d1883956 61 fields · synced May 30, 2026
- FDA UDI 8989ec85-77dd-4c14-a750-33b305b1c64e 34 fields · synced May 30, 2026