Data / Medical devices / Germany / Fischer Analysen Instrumente GMBH
Fischer Analysen Instrumente GMBH: FDA-registered device maker in Leipzig Saxony, Germany, 1 PMA approval
Fischer Analysen Instrumente GMBH is registered with the FDA (registration 3010837197) in Leipzig Saxony, Germany. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated February 18, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010837197
- Address
- Brahestr. 25-27, Leipzig Saxony, Germany, 04347
- Owner or operator
- Fischer ANalysen Instrumente GmbH (10062455)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 5, 2020
- Registered through
- 2026
- Brand names listed
- PyloPlus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Test, Urea Adult And Pediatric (Breath), | OZA | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 18, 2020 | P170022 | PyloPlus UBT System | OZA | 6 | February 5, 2026 | accessdata.fda.gov |
Updated February 5, 2026. 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.