Data / Medical devices / Germany / Ulrich GMBH & Co. KG
Ulrich GMBH & Co. KG: FDA-registered device maker in Dornstadt Baden-Wurttemberg, Germany, 2 510(k) clearances
Ulrich GMBH & Co. KG is registered with the FDA (registration 3040111919) in Dornstadt Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3040111919
- Address
- Lerchenbergstrasse 15, Dornstadt Baden-Wurttemberg, Germany, 89160
- Owner or operator
- ULRICH GMBH & CO. KG (8010776)
- Roles
- Manufacturer
- First device listed
- November 25, 2025
- Registered through
- 2026
- Brand names listed
- ulrichINJECT CT motion, ulricheasyINJECT Max
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector, Contrast Medium, Automatic | IZQ | 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 |
|---|---|---|---|---|---|---|
| November 18, 2025 | K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | IZQ | Substantially Equivalent | Ulrich GmbH & Co. KG | accessdata.fda.gov |
| November 7, 2025 | K251295 | ulrichINJECT CT Motion (XD 8000) | IZQ | Substantially Equivalent | Ulrich GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
Updated November 18, 2025. 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.