FDA Registration
Active
🇸🇪 Sweden
FILLAUER EUROPE
Reg #: 9681133
·
FEI: 3005564811
·
Expires 2026
Products
7
Proprietary Names
33
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- FILLAUER EUROPE
- Registration Number
- 9681133
- FEI Number
- 3005564811
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 1992-08-05 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2003-04-09 |
| Hand, External Limb Component, Mechanical | IRA | Class 1 | Physical Medicine | No | 2002-05-31 |
| Valve, Prosthesis | ISP | Class 1 | Physical Medicine | No | 2004-04-21 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2003-04-09 |
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 1998-11-30 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2023-09-27 |
Proprietary Names
Foot Orthotics
SPL CTO
RGO Clinical Trial Orthosis (CTO)
Hand Shell
Footshell
NEO Axilla Loop Padding
Procover
Arm Skinz
Foam Cover
Dreamskin
Natural Definition cosmetic gloves and covers
Absolute Sleeve
Mechanical Hands
Passive Hands
Prosthetic Recreational Terminal Devices
Prosthetic Valves
MightyMite Components
Shuttle Lock
Endoskeletal Alignment System
ALP adaptors
Clutch Lock
AP&ML Unit
Gator Grip
Wrist Lock
Structural Components
Prosthetic Alignment Devices
Elbow (E-400, E-200, E-50)
Hinges (E-500, E-1500, E-2500, SP-100)
Prefabricated Forearms
Endoarm
Shoulder Joints
Ener-joint Elbow
Dynamic Walk
Establishment Types
Manufacture Medical Device