Data / Medical devices / Germany / Hidrex GMBH
Hidrex GMBH: FDA-registered device maker in Heiligenhaus North Rhine-Westphalia, Germany, 1 510(k) clearance
Hidrex GMBH is registered with the FDA (registration 3008642982) in Heiligenhaus North Rhine-Westphalia, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 8, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008642982
- Address
- Otto-Hahn-Str. 12, Heiligenhaus North Rhine-Westphalia, Germany, 42579
- Owner or operator
- Hidrex GmbH (10049191)
- Roles
- Manufacturer
- First device listed
- April 27, 2015
- Registered through
- 2026
- Brand names listed
- Aquex DAAV1000, HIDREX DP450, HIDREX DVP1000, Phothera Aquex (HIPRO10)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Iontophoresis, Other Uses | EGJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 8, 2015 | K133033 | HIDREX PSP1000 | EGJ | Substantially Equivalent | Hidrex GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 30, 2017 | 76362 | Class III | Terminated | Hidrex USA DP450 | The device was reclassified from a class III device to a class II device and there are new documentation requirements. | accessdata.fda.gov |
Compare with other makers
Updated February 22, 2017. 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.