Data / Medical devices / Germany / Saalmann Medical GMBH & Co. KG
Saalmann Medical GMBH & Co. KG: FDA-registered device maker in Bad Oeynhausen North Rhine-Westphalia, Germany, 1 510(k) clearance
Saalmann Medical GMBH & Co. KG is registered with the FDA (registration 3016463808) in Bad Oeynhausen North Rhine-Westphalia, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 18, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016463808
- Address
- Suedbahnstrasse 34, Bad Oeynhausen North Rhine-Westphalia, Germany, 32547
- Owner or operator
- Saalmann medical GmbH & Co. KG (10062464)
- Roles
- Manufacturer
- First device listed
- January 30, 2020
- Registered through
- 2026
- Brand names listed
- Saalio, The Fischer
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 |
|---|---|---|---|---|---|---|
| October 18, 2019 | K191436 | Saalio | EGJ | Substantially Equivalent | Saalmann Medical GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
Updated October 18, 2019. 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.