Identity
- Trade Name
- Dx-Recorder EUDAMEDRestech FDA UDI
- Generic Name
- Gastric pH ambulatory recorder FDA UDI
- Device Name
- Dx-Recorder EUDAMEDDx-500 Recorder - Part of the Dx-1000 pH Measurement system. The pH data Recorder is intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders. FDA UDI
- Model / Reference
- Dx-500 EUDAMEDFDA UDI
- Description
- Dx-500 Recorder - Part of the Dx-1000 pH Measurement system. The pH data Recorder is intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899994002127 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00899994002127 EUDAMED
- FDA Product Code
- FFT FDA UDI
- EMDN Code
- G030702 PH MONITORING DEVICES EUDAMED
- GMDN Term
- Gastric pH ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.1400 FDA UDI
- Market of Registration
- Poland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Dx-Recorder by Respiratory Technology Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00899994002127 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respiratory Technology Corporation
- EUDAMED SRN
- US-MF-000009086
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 57ee9ac5-962f-410c-9f48-fced0916fdbb 61 fields · synced Jul 17, 2026
- FDA UDI 6a943f59-b36c-419e-9a45-5fd161d0e119 34 fields · synced May 30, 2026