FDA Registration Active 🇳🇱 Netherlands

Mesh Top Post-Op Shoe

Reg #: 3004161950 · FEI: 3004161950 · Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1

Registration Details

Registration Name
OSSUR EUROPE B.V.
Registration Number
3004161950
FEI Number
3004161950
Status
Active
Expiry Year
2025
Initial Importer
No
Address
De Schakel 70
City
Eindhoven Noord-Brabant
Country
NL

Owner / Operator

Firm Name
OSSUR Americas
Operator Number
9026971
Address
200 Spectrum Center Drive, Suite 700
City
Irvine
State
CA
Postal Code
92618
Country
US

US Agent

Business Name
Ossur
Contact Name
Katla Axelsdottir
Address
200 Spectrum Center Drive, Suite 700
City
Irvine
State
CA
ZIP
92618
Country
US
Phone
949 3823833

Products

Device Name Product Code
Shoe, Cast IPG

Proprietary Names

Mesh Top Post-Op Shoe Square Top Post-Op Shoe Pediatric Cast Sandal with Rocker Sole Soft Top Post-Op Shoe Canvas Rocker Bottom Cast Shoe DH Offloading Post-Op Style shoe

Establishment Types

Export Device to the United States But Perform No Other Operation on Device