FDA Registration
Active
🇨🇭 Switzerland
SPI ONETIME
Reg #: 3003184527
·
FEI: 3003184527
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- THOMMEN MEDICAL, AG
- Registration Number
- 3003184527
- FEI Number
- 3003184527
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NECKARSULMSTRASSE 28
- City
- GRENCHEN Solothurn
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K022038
Owner / Operator
- Firm Name
- THOMMEN MEDICAL, AG
- Operator Number
- 9051144
- Address
- NECKARSULMSTRASSE 28, --
- City
- Grenchen
- State
- CH-NOTA
- Postal Code
- 2540
- Country
- CH
US Agent
- Business Name
- THOMMEN MEDICAL USA, LLC
- Contact Name
- JOE GALEA
- Address
- 1375 Euclid Avenue, Suite 450
- City
- Cleveland
- State
- OH
- ZIP
- 44115
- Country
- US
- [email protected]
- Phone
- 216 5839800
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2007-11-05 |
Proprietary Names
SPI ONETIME
Establishment Types
Manufacture Medical Device