FDA Registration
Active
🇸🇪 Sweden
Elbow (E-400, E-200, E-50)
Reg #: 9681133
·
FEI: 3005564811
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FILLAUER EUROPE
- Registration Number
- 9681133
- FEI Number
- 3005564811
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KUNG HANS VAG 2, 192 68 SOLLENTUNA
- City
- JARFALLA Stockholm
- Country
- SE
Owner / Operator
- Firm Name
- FILLAUER COMPANIES, INC.
- Operator Number
- 9910012
- Address
- 2710 AMNICOLA HWY.
- City
- Chattanooga
- State
- TN
- Postal Code
- 37406
- Country
- US
- Correspondent
- Annette Cole
US Agent
- Business Name
- FILLAUER LLC
- Contact Name
- Annette Cole
- Address
- 2710 AMNICOLA HWY.
- City
- CHATTANOOGA
- State
- TN
- ZIP
- 37406
- Country
- US
- [email protected]
- Phone
- 423 6240946
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 1998-11-30 |
Proprietary Names
Elbow (E-400, E-200, E-50)
Ener-joint Elbow
Shoulder Joints
Prefabricated Forearms
Hinges (E-500, E-1500, E-2500, SP-100)
Endoarm
Establishment Types
Manufacture Medical Device