Identity
- Trade Name
- Dx-pH Probe EUDAMEDRestech FDA UDI
- Generic Name
- Gastric pH ambulatory recorder FDA UDI
- Device Name
- Dx-pH Probe EUDAMEDpH probe. Intended for oropharyngeal pH measurement. FDA UDI
- Model / Reference
- Dx-201 EUDAMEDDx-201 pH probe CAS FDA UDI
- Description
- pH probe. Intended for oropharyngeal pH measurement. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899994002004 EUDAMED00899994002097 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00899994002004 EUDAMEDB-00899994002097 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
- Italy EUDAMEDPoland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
EUDAMEDEUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dx-pH Probe 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-00899994002004 | 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 (3)
- EUDAMED b4ada410-fd01-47e7-8e7a-edc05e3450de 61 fields · synced Sep 17, 2026
- EUDAMED f47bd9b4-c657-4c4f-aa56-c33f889e56b9 61 fields · synced May 16, 2026
- FDA UDI 61b0da7e-0eeb-4a06-b32b-3e38b4f6f68b 34 fields · synced May 30, 2026