FDA Registration
Active
🇳🇱 Netherlands
NEURO HiSWING AFO
Reg #: 3004161950
·
FEI: 3004161950
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSSUR EUROPE B.V.
- Registration Number
- 3004161950
- FEI Number
- 3004161950
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- De Schakel 70
- City
- Eindhoven Noord-Brabant
- Country
- NL
Owner / Operator
- Firm Name
- OSSUR Americas
- Operator Number
- 9026971
- Address
- 200 Spectrum Center Drive, Suite 700
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
US Agent
- Business Name
- Ossur
- Contact Name
- Katla Axelsdottir
- Address
- 200 Spectrum Center Drive, Suite 700
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 3823833
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2006-10-18 |
Proprietary Names
NEURO HiSWING AFO
Rebound Dual ST
Formfit Pro Knee Flite
Rebound Dual
Rebound Dual Recover
Formfit Pro Knee Quest
Formfit Tracker
Rebound Dual Basic
Rebound Dual Basic ST
Rebound DUAL ST Custom
Rebound DUAL Custom
NEURO SWING Carbon AFO
NEURO SWING 2 AFO
NEURO SWING AFO
Establishment Types
Export Device to the United States But Perform No Other Operation on Device