FDA Registration
Active
🇳🇱 Netherlands
Universal Abdominal Binder
Reg #: 3004161950
·
FEI: 3004161950
·
Expires 2025
Products
1
Proprietary Names
5
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 |
|---|---|---|---|---|---|
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 1991-02-21 |
Proprietary Names
Universal Abdominal Binder
Elastic Abdominal Binder
Dual Maternity Belt
Universal Elastic Rib Belt
Temporary Hernia Support
Establishment Types
Export Device to the United States But Perform No Other Operation on Device