Data / Medical devices / Germany / Humanoptics Holding AG
Humanoptics Holding AG: FDA-registered device maker in Sankt Augustin North Rhine-Westphalia, Germany, 1 PMA approval
Humanoptics Holding AG is registered with the FDA (registration 3010531293) in Sankt Augustin North Rhine-Westphalia, Germany. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated May 30, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010531293
- Address
- Westerwaldstr. 11-13, Sankt Augustin North Rhine-Westphalia, Germany, 53757
- Owner or operator
- HumanOptics Holding AG (10058390)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 10, 2018
- Registered through
- 2027
- Brand names listed
- ARTIFICIALIRIS FiberFree CUSTOMFLEX®, ARTIFICIALIRIS FiberFree SELECT Dark Blue, ARTIFICIALIRIS FiberFree SELECT Dark Brown, ARTIFICIALIRIS FiberFree SELECT Dark Green, ARTIFICIALIRIS FiberFree SELECT Light Blue, ARTIFICIALIRIS FiberFree SELECT Light Brown, ARTIFICIALIRIS FiberFree SELECT Light Green, ARTIFICIALIRIS FiberFree SELECT Medium Blue and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Artificial Iris | QBT | 3 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| May 30, 2018 | P170039 | CustomFlex Artificial Iris | QBT | 3 | September 4, 2020 | accessdata.fda.gov |
Updated September 4, 2020. 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.