Data / Medical devices / Cystometer, Electrical Recording
Cystometer, Electrical Recording (EXQ): 12 FDA-registered makers in 7 countries
12 establishments in 7 countries are registered with the FDA to make Cystometer, Electrical Recording (product code EXQ, Class 2, 21 CFR 876.1620). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on April 16, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EXQ
- Device class
- 2
- Regulation
- 876.1620
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 2 |
| India | 2 |
| Italy | 1 |
| Netherlands | 1 |
| United Kingdom | 1 |
| China | 1 |
Makers of Cystometer, Electrical Recording
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bright Uro, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 2 | April 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cal-Comp Usa | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Delta Med SPA | Delebio Sondrio, Italy | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Demcon Production B.V. | Enschede Overijssel, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digitimer Ltd. | Welwyn Garden City Hertfordshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laborie Medical Technologies Corp. | Portsmouth, NH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Linx (asia) Trading Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rheme GmbH | Stuttgart Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Santron Meditronic | Pune Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SRS Medical | Chelmsford, MA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Status Medical Equipments India Private Limited | Satara Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.