FDA Registration
Active
🇫🇷 France
Blue Ortho
Reg #: 3008027912
·
FEI: 3008027912
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BLUE ORTHO
- Registration Number
- 3008027912
- FEI Number
- 3008027912
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 22 Chemin du Vieux Chene
- City
- Meylan Isere
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K152764
Owner / Operator
- Firm Name
- BLUE ORTHO
- Operator Number
- 10037278
- Address
- 22 Chemin du Vieux Chene
- City
- Meylan
- State
- Isere
- Postal Code
- 38240
- Country
- FR
- Correspondent
- Matthieu COIC
US Agent
- Business Name
- Exactech Inc
- Contact Name
- Matt Collins
- Address
- 2320 NW 66th Ct
- City
- Gainesville
- State
- FL
- ZIP
- 32653
- Country
- US
- [email protected]
- Phone
- 352 3771140
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2016-11-08 |
Proprietary Names
Blue Ortho
Establishment Types
Manufacture Medical Device