FDA Registration
Active
🇸🇪 Sweden
Tranberg CLS Introducer/Trocar MRI Compatible
Reg #: 3012452798
·
FEI: 3012452798
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- CLINICAL LASERTHERMIA SYSTEMS AB
- Registration Number
- 3012452798
- FEI Number
- 3012452798
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Scheelevagen 2
- City
- Lund Skane
- Country
- SE
Owner / Operator
- Firm Name
- Clinical Laserthermia Systems AB
- Operator Number
- 10050452
- Address
- Scheelevagen 2
- City
- Lund
- State
- Skane
- Postal Code
- 22381
- Country
- SE
- Correspondent
- Lars-Erik Eriksson
US Agent
- Business Name
- OMEDtech, LLC
- Contact Name
- David Makanani
- Address
- 8501 Lullwater Dr, # 1208
- City
- Dallas
- State
- TX
- ZIP
- 75238
- Country
- US
- [email protected]
- Phone
- 405 8260713
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Trocar | DRC | Class 2 | Cardiovascular | No | 2016-05-04 |
Proprietary Names
Tranberg CLS Introducer/Trocar MRI Compatible
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device