FDA Registration
Active
🇩🇪 Germany
Otoscope OX2
Reg #: 3009010438
·
FEI: 3009010438
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORLVISION GMBH
- Registration Number
- 3009010438
- FEI Number
- 3009010438
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gewerbestrasse 17
- City
- Lahnau Hesse
- Country
- DE
Owner / Operator
- Firm Name
- Orlvision GmbH
- Operator Number
- 10061627
- Address
- Gewerbestrasse 17
- City
- Lahnau
- State
- Hesse
- Postal Code
- 35633
- Country
- DE
- Correspondent
- Oliver Neumann
US Agent
- Business Name
- IT Concepts LLC
- Contact Name
- Alla Balashov
- Address
- 1244-B Quarry Lane
- City
- Pleasanton
- State
- CA
- ZIP
- 94566
- Country
- US
- [email protected]
- Phone
- 925 4010010 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2020-03-07 |
Proprietary Names
Otoscope OX2
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device