FDA Registration
Active
🇨🇭 Switzerland
ORTEK AG
Reg #: 3003061090
·
FEI: 3003061090
·
Expires 2026
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ORTEK AG
- Registration Number
- 3003061090
- FEI Number
- 3003061090
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- INDUSTRIE NORD 5
- City
- MERENSCHWAND Aargau
- Country
- CH
Owner / Operator
- Firm Name
- ORTEK AG
- Operator Number
- 9064081
- Address
- INDUSTRIE NORD 5, --
- City
- MERENSCHWAND
- State
- Aargau
- Postal Code
- CH-5634
- Country
- CH
- Correspondent
- HANS - BACHMANN
US Agent
- Business Name
- FDAbasics
- Contact Name
- Emiliy Matorin
- Address
- 1 Prospect Park W Apt 4d
- City
- Brooklyn
- State
- NY
- ZIP
- 11215
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2024-03-04 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-11-13 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2013-01-03 |
Proprietary Names
RENOVIS BIPOLAR HIP SYSTEM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)