Data / Medical devices / Germany / iSYS Medizintechnik GmbH
iSYS Medizintechnik GmbH: FDA-registered device maker in Untermeitingen Bavaria, Germany, 2 510(k) clearances
iSYS Medizintechnik GmbH is registered with the FDA (registration 3013847349) in Untermeitingen Bavaria, Germany. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013847349
- Address
- Ulrichstrasse 40, Untermeitingen Bavaria, Germany, 86836
- Owner or operator
- ISYS Medizintechnik GmbH (10052093)
- Roles
- Manufacturer
- First device listed
- June 14, 2016
- Registered through
- 2026
- Brand names listed
- IFix, Micromate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Restraint, Protective | FMQ | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 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 10, 2023 | K230130 | Micromate Navi+ | JAK | Substantially Equivalent | Isys Medizintechnik GmbH | accessdata.fda.gov |
| June 22, 2021 | K203720 | MICROMATE | JAK | Substantially Equivalent | Isys Medizintechnik GmbH | accessdata.fda.gov |
Compare with other makers
Updated October 10, 2023. 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.