FDA Registration
Active
🇩🇪 Germany
ERGOLINE GMBH
Reg #: 3005438755
·
FEI: 3005438755
·
Expires 2026
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ERGOLINE GMBH
- Registration Number
- 3005438755
- FEI Number
- 3005438755
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LINDENSTR. 5
- City
- BITZ Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K212883
Owner / Operator
- Firm Name
- ERGOLINE GMBH
- Operator Number
- 9078941
- Address
- LINDENSTR. 5, --
- City
- BITZ, B-W
- State
- DE-NOTA
- Postal Code
- 72475
- Country
- DE
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Treadmill, Powered | IOL | Class 1 | Physical Medicine | No | 2012-04-18 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2022-08-17 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2010-12-02 |
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2023-02-03 |
Proprietary Names
ergocar PC/basic
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device