Data / Medical devices / Germany / Injex Pharma GMBH
Injex Pharma GMBH: FDA-registered device maker in Berlin, Germany, 1 510(k) clearance
Injex Pharma GMBH is registered with the FDA (registration 3009339779) in Berlin, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009339779
- Address
- Beeskowdamm 6, Berlin, Germany, 14167
- Owner or operator
- Injex Pharma GmbH (10039796)
- Roles
- Manufacturer
- First device listed
- February 10, 2012
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector, Fluid, Non-Electrically Powered | KZE | 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 |
|---|---|---|---|---|---|---|
| September 25, 2002 | K020786 | INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM | KZE | Substantially Equivalent | Rosch AG Medizintechnic | accessdata.fda.gov |
Compare with other makers
Updated September 25, 2002. 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.