FDA Registration
Active
🇨🇴 Colombia
TECHFIT Diagnostic Models
Reg #: 3004187715
·
FEI: 3004187715
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INDUSTRIAS MEDICAS SAMPEDRO S.A.S
- Registration Number
- 3004187715
- FEI Number
- 3004187715
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Carrera 47 100 Sur 40 Bodega 14
- City
- La Estrella Antioquia
- Country
- CO
Regulatory Submissions
- 510(k) Number
- K222577
Owner / Operator
- Firm Name
- INDUSTRIAS MEDICAS SAMPEDRO S.A.S
- Operator Number
- 10062588
- Address
- Carrera 47 100 Sur 40 Bodega 14
- City
- La Estrella
- State
- Antioquia
- Postal Code
- 055468
- Country
- CO
- Correspondent
- Maritza Buitrago-Vasquez
US Agent
- Business Name
- Techfit Digital Surgery Inc
- Contact Name
- Laura Buitrago
- Address
- 1511 Aviation Center Pkwy Ste 220H, Daytona Beach, Florida, 32114, UNITED STATES
- City
- Daytona Beach
- State
- FL
- ZIP
- 32114
- Country
- US
- [email protected]
- Phone
- 929 2488135
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-02-23 |
Proprietary Names
TECHFIT Diagnostic Models
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)