FDA Registration Active 🇨🇴 Colombia

Techfit Disrp® System

Reg #: 3004187715 · FEI: 3004187715 · Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2

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
K230276

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
Phone
929 2488135

Products

Device Name Product Code
System, Image Processing, Radiological LLZ
Driver, Wire, And Bone Drill, Manual DZJ

Proprietary Names

Techfit Disrp® System

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)