Identity
- Trade Name
- Dx-pH Measurement System EUDAMEDRestech FDA UDI
- Generic Name
- Gastric pH ambulatory recorder FDA UDI
- Device Name
- Dx-pH Measurement System EUDAMEDThe Restech Dx–pH Measurement System is intended for gastroesophageal pH measurement and monitoring of gastric reflux. The pH data Recorder and data viewing program are intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders. FDA UDI
- Model / Reference
- DX-1000 EUDAMEDFDA UDI
- Description
- The Restech Dx–pH Measurement System is intended for gastroesophageal pH measurement and monitoring of gastric reflux. The pH data Recorder and data viewing program are intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899994002103 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00899994002103 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-pH Measurement System 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-00899994002103 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respiratory Technology Corporation
- EUDAMED SRN
- US-MF-000009086
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED d6426eec-c343-4f35-bcc6-e169abe306b4 61 fields · synced Jul 15, 2026
- FDA UDI ad2b99c1-9664-41dc-865a-cbb48ee79106 34 fields · synced May 30, 2026