FDA Registration Active 🇷🇴 Romania

Stat-A-Dyne Knee

Reg #: 3011678115 · FEI: 3011678115 · Expires 2025
Products
1
Proprietary Names
65
Establishment Types
2
Classifications
1

Registration Details

Registration Name
Textile Medicale
Registration Number
3011678115
FEI Number
3011678115
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Zona Industriala de Vest, Str. III, NR.1
City
Arad
Country
RO

Owner / Operator

Firm Name
Thuasne, LLC
Operator Number
9011981
Address
120 Osage Ave
City
Kansas City
State
KS
Postal Code
66105
Country
US

US Agent

Business Name
Registrar Corp
Contact Name
David Lennarz
Address
144 Research Drive
City
Hampton
State
VA
ZIP
23666
Country
US
Phone
757 2240177

Products

Device Name Product Code
Orthosis, Limb Brace IQI

Proprietary Names

Stat-A-Dyne Knee SpryStep Footplate Stat-A-Dyne Ankle Premier Softforce Reliever Premier Reliever Air Townsend Reliever Premier Trigger Bold Full Shell KAFO Premier KAFO Active Reliever Genu Ligaflex Silistab Genu Reliever Reliever One TS ROM Action Reliever ROMX SS Reliever Air RebelPro Rebel Reliever Genu Ligaflex ROM Sports Series Genuextrem Motocross Series Full Shell BK Air Townsend Rebel ROM 6 Genu Pro Activ Dynamic KAFO Rebel Lock Full Shell Patella Reliever Genu Dynastab Dynamic Reliever ROM 4 ROM-R PR1 Reliever Air Lite ExoGuard Ligastrap Genu Compression Socks Genu ProMaster Compression Calf Sleeves GenuStart GenuStart ROM Rebel 3D Argicalm Th Sport SPRYSTEP VECTOR KAFO ROM-LX SpryStep OA UniReliever SpryStep Carbon Footplate Select Reliever The Crusader Stat-A-Dyne Wrist SpryStep Ligament Stat-A-Dyne Shoulder SpryStep Neuro Stat-A-Dyne Elbow Stat-A-Dyne ESP Stat-A-Dyne WHFO Stat-A-Dyne Pronation / Supination

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device