FDA Registration
Active
🇩🇪 Germany
OD-OS GMBH
Reg #: 3008252121
·
FEI: 3008252121
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OD-OS GMBH
- Registration Number
- 3008252121
- FEI Number
- 3008252121
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Warthestr. 21
- City
- Teltow Brandenburg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K162191
Owner / Operator
- Firm Name
- OD-OS GmbH
- Operator Number
- 10031430
- Address
- Warthestr. 21
- City
- Teltow
- State
- Brandenburg
- Postal Code
- 14513
- Country
- DE
US Agent
- Business Name
- OD-OS, Inc
- Contact Name
- Trey Pleasants
- Address
- 6201 Oak Cyn Ste 200
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 4157256
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2017-11-21 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2017-11-21 |
| Device, Storage, Images, Ophthalmic | NFF | Class 1 | Radiology | No | 2017-11-21 |
| Device, Communications, Images, Ophthalmic | NFG | Class 1 | Radiology | No | 2017-11-21 |
Establishment Types
Manufacture Medical Device