Restech
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…
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.
Who Else Makes It
Registered in Chongqing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Jinshan Science & Technology (Group) Co., Ltd. | Chongqing | Chongqing | Manufacturer | 4 |
Record
| Listed by | THE Reflux Company, United States |
|---|---|
| FDA product code | FFT |
| Device type | Electrode, Ph, Stomach |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1400 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-02 |
| Record revised | 2025-12-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Dx-201 P | In distribution | |
| Dx-300 | In distribution | |
| Dx-500 | In distribution | |
| Dx-201 pH probe CAS | In distribution | |
| Dx-201 L | In distribution | |
| Dx-1000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diversatek Healthcare | Diversatek Healthcare Inc | 36 |
| Versaflex | Given Imaging Ltd. | 35 |
| Bravo | Given Imaging Ltd. | 9 |
| Heidelberg pH Capsule System | Heidelberg Medical Inc | 7 |
| alpHaONE | Chongqing Jinshan Science & Technology (Group) Co., Ltd. | 4 |
| Electrode, Ph, Stomach | Given Imaging Ltd. | 3 |
| Reflux | Given Imaging Ltd. | 2 |
| 2 channel pH antimony, 21 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 2 channel pH antimony, 15 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 2 channel pH antimony, 10 cm spacing, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| 1 channel pH antimony, 6.4 Fr | Medical Measurement Systems B.V. | 1 |
| Digitrapper | Given Imaging Ltd. | 1 |
Showing 12 of 14. All products under Electrode, Ph, Stomach
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.