FDA Registration
Active
🇩🇪 Germany
Octax LaserShotM
Reg #: 3003843927
·
FEI: 3003843927
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Vitrolife GmbH
- Registration Number
- 3003843927
- FEI Number
- 3003843927
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Roedersteinstrasse 6
- City
- Landshut Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K192008
Owner / Operator
- Firm Name
- Vitrolife GmbH
- Operator Number
- 9087379
- Address
- Roedersteinstrasse, 6
- City
- Landshut
- State
- DE-NOTA
- Postal Code
- 84034
- Country
- DE
- Correspondent
- SUSANNE - SCHWEITZER
US Agent
- Business Name
- Vitrolife Inc
- Contact Name
- Eli Soto
- Address
- 3601 S Inca St.
- City
- Englewood
- State
- CO
- ZIP
- 80110
- Country
- US
- [email protected]
- Phone
- 303 7621933
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Assisted Reproduction Laser | MRX | Class 2 | Obstetrics/Gynecology | No | 2020-04-06 |
Proprietary Names
Octax LaserShotM
Octax NaviLase
Establishment Types
Manufacture Medical Device