Data / Medical devices / Germany / Metasystems GMBH
Metasystems GMBH: FDA-registered device maker in ALTLUSSHEIM Baden-Wurttemberg, Germany, 1 510(k) clearance
Metasystems GMBH is registered with the FDA (registration 9680625) in ALTLUSSHEIM Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 24, 1995. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9680625
- FEI number
- 3003342560
- Address
- Robert-Bosch-Str. 6, ALTLUSSHEIM Baden-Wurttemberg, Germany, D-68804
- Owner or operator
- METASYSTEMS GMBH (9010226)
- Roles
- Manufacturer
- First device listed
- October 21, 2003
- Registered through
- 2027
- Brand names listed
- Ikaros, Isis, Metafer, NEON
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chromosome, Automated | LNJ | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Fluorescence/U.V. | IBK | 1 | 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 |
|---|---|---|---|---|---|---|
| February 24, 1995 | K940240 | IKAROS | LNJ | Substantially Equivalent | Metasystems GmbH | accessdata.fda.gov |
Compare with other makers
Updated February 24, 1995. 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.