FDA Registration
Active
🇲🇺 Mauritius
NATEC MEDICAL LTD
Reg #: 3004415014
·
FEI: 3004415014
·
Expires 2026
Products
4
Proprietary Names
20
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- NATEC MEDICAL LTD
- Registration Number
- 3004415014
- FEI Number
- 3004415014
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ava Technopark, Med tech road, Cote DOr Technopole, Minissy, Cote DOr
- City
- Moka
- Country
- MU
Regulatory Submissions
- 510(k) Number
- K251915
Owner / Operator
- Firm Name
- NATEC MEDICAL LTD
- Operator Number
- 9060577
- Address
- Ava Technopark, Med tech road, Cote DOr Technopole, Minissy, Cote DOr
- City
- Moka
- State
- MU-NOTA
- Postal Code
- 80829
- Country
- MU
- Correspondent
- VINCENT - LAGARDE
US Agent
- Business Name
- CardioMed Device Consultants, LLC
- Contact Name
- Semih Oktay H. Semih Oktay
- Address
- 1783 Forest Drive #254 Annapolis
- City
- Annapolis
- State
- MD
- ZIP
- 21401
- Country
- US
- [email protected]
- Phone
- 410 6742060
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2026-01-20 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2013-03-01 |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2016-01-14 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2024-12-18 |
Proprietary Names
Amethyst HP PTA OTW 035" Catheter
EBONY 14" PTA catheters
USE014
Ebony 014" PTA Rx Catheter
Ebony PTA 035OTW
USE 035
Amethyst HP PTA OTW 035
EBONY 14'' PTA Catheters
USE 014/018otw
Ebony PTA 014/018 OTW
Ebony 014" PTA OTW Catheter, Ebony 018" PTA OTW Catheter, Victory 014" & 018" PTA OTW Catheter
FILAO NC
Filao NC RX PTCA Dilatation Catheter
Tamarin Blue PTCA Rx Dilatation Catheter
USE014 RX
Ebony PTA014RX
Tamarin Blue PTCA Catheters
Ebony HP PTA OTW 035
Ebony HP PTA OTW 035" Catheter, Victory HP PTA OTW 035" Catheter
USE 035 OTW
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)