FDA Registration
Active
🇩🇪 Germany
SoloAsisst II, Voice Control
Reg #: 3011390076
·
FEI: 3011390076
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AKTORmed GmbH
- Registration Number
- 3011390076
- FEI Number
- 3011390076
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Neugablonzer Strasse 13
- City
- Neutraubling Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K200473
Owner / Operator
- Firm Name
- AKTORmed GmbH
- Operator Number
- 10059606
- Address
- Neugablonzer Strasse 13
- City
- Neutraubling
- State
- Bavaria
- Postal Code
- 93073
- Country
- DE
- Correspondent
- Robert Geiger
US Agent
- Business Name
- Micro Epsilon America
- Contact Name
- Martin Dumberger
- Address
- 8120 Browneigh Road
- City
- Raleigh
- State
- NC
- ZIP
- 27617
- Country
- US
- [email protected]
- Phone
- 919 7879707
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2021-01-05 |
Proprietary Names
SoloAsisst II, Voice Control
Establishment Types
Manufacture Medical Device