FDA Registration
Active
🇳🇱 Netherlands
Livingskin Above Elbow
Reg #: 3004161950
·
FEI: 3004161950
·
Expires 2025
Products
1
Proprietary Names
10
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 |
|---|---|---|---|---|---|
| Hand, External Limb Component, Mechanical | IRA | Class 1 | Physical Medicine | No | 2004-01-07 |
Proprietary Names
Livingskin Above Elbow
Livingskin Full hand
Livingskin Partial finger
Livingskin Partial hand
Livingskin Foot
Livingskin Below elbow
Livingskin Finger band
Livingskin Full finger
Livingskin Toe
Livingskin
Establishment Types
Export Device to the United States But Perform No Other Operation on Device