FDA Registration
Active
🇨🇭 Switzerland
SPHINX TOOLS LTD
Reg #: 9614438
·
FEI: 3010871687
·
Expires 2026
Products
15
Proprietary Names
9
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- SPHINX TOOLS LTD
- Registration Number
- 9614438
- FEI Number
- 3010871687
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Gewerbestrasse 1
- City
- Derendingen Solothurn
- Country
- CH
Owner / Operator
- Firm Name
- Sphinx Tools Ltd
- Operator Number
- 10028077
- Address
- Gewerbestrasse 1
- City
- Derendingen
- State
- Solothurn
- Postal Code
- 4552
- Country
- CH
- Correspondent
- Manuel Kummer
US Agent
- Business Name
- confinis USA Inc.
- Contact Name
- Alfred Lerch
- Address
- 600 Park Offices Drive Suite 300, Unit #50
- City
- Durham
- State
- NC
- ZIP
- 27709
- Country
- US
- [email protected]
- Phone
- 910 2289391
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2016-02-19 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2008-12-29 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2008-12-29 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-01-22 |
| Template | HWT | Class 1 | Orthopedic | No | 2017-04-19 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2017-04-19 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2017-04-19 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-10-11 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-10-11 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2016-12-12 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2019-10-28 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-01-22 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2017-04-19 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-22 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2017-04-19 |
Proprietary Names
Fairfax
FibreKor
SYNTHES
Zimmer GMBH
MEDARTIS INC.
INTEGRA YORK PA INC.
CMF MEDICON SURGICAL
9613350
CMF Medicon Surgical Inc
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)