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Sign in to claim this brandVitrolife GmbH
Germany·DE-MF-000007378
Last updated September 17, 2026
Information
- Country
- Germany
- Address
- 6, Roedersteinstrasse, Landshut, Germany
- Website
- www.vitrolife.com
- —
- —
- [email protected]
- Phone
- +49871430657-29
- PRRC Contact
- Christoph Hönl
- EUDAMED SRN
- DE-MF-000007378
- FDA FEI Number
- 3003843927
- DUNS Number
- —
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LaserShot M, NaviLase | K192008 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Octax NaviLase upgrade | 19310/0147 | EUDAMED | Class IIa | Active |
| Octax NaviLase | 19310/0146 | EUDAMEDFDA UDI | Class IIa | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 22, 2014 | Z-1448-2015 | — | terminated | The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added. |
| May 12, 2011 | Z-2795-2011 | — | terminated | Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Vitrolife AB San Diego, CA · US FEI 3002757762