FDA Registration
Active
🇨🇭 Switzerland
Instruments for T2 ICF System
Reg #: 3010287665
·
FEI: 3010287665
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Europtec AG Polymer
- Registration Number
- 3010287665
- FEI Number
- 3010287665
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Aeschwurstrasse 30
- City
- Oftringen Aargau
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K193366
Owner / Operator
- Firm Name
- Europtec Polymer AG
- Operator Number
- 10043579
- Address
- Aeschwurstrasse 30
- City
- Oftringen
- State
- Aargau
- Postal Code
- 4665
- Country
- CH
- Correspondent
- Martin Brand
US Agent
- Business Name
- LDJCG LLC
- Contact Name
- Lance Johnson
- Address
- 102 Bobwhite Cove
- City
- Dripping Springs
- State
- TX
- ZIP
- 78620
- Country
- US
- [email protected]
- Phone
- 512 7757610
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-07-06 |
Proprietary Names
Instruments for T2 ICF System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)