FDA Registration
Active
🇨🇭 Switzerland
OptiVu Streamer R2.1
Reg #: 3020521079
·
FEI: 3020521079
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INCREMED AG
- Registration Number
- 3020521079
- FEI Number
- 3020521079
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Bubenbergstrasse 1
- City
- Zurich
- Country
- CH
Owner / Operator
- Firm Name
- Incremed AG
- Operator Number
- 10082674
- Address
- Bubenbergstrasse 1
- City
- Zürich
- State
- Zurich
- Postal Code
- 8045
- Country
- CH
- Correspondent
- Samuel Hertig
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2022-11-10 |
Proprietary Names
OptiVu Streamer R2.1
SonoEyes R2
OptiVu Streamer R2
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device