Main Section «y» Size Large (Monocore)

by Turbomed Orthotics inc. EUDAMED

Active European Union

Ref 201000-Y00-L

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number62055328200000GY Basic UDI-DI	Date17 Jan 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name: Xtern Foot Drop Orthotics - Plastic Parts Replacement
Model / Reference: 201000-Y00-L

Primary DI / UDI-DI: 00620553281420

Market of Registration: Sweden

Manufacturer details

EUDAMED SRN: CA-MF-000032108
Authorised representative: OKO SOLUTION FR-AR-000006781

Other devices from Turbomed Orthotics inc.

Xtern Frontier Anterior Foot Drop Orthotic Size Small

Class I
Xtern Summit Foot Drop Orthotic, Size Large

Class I
Shin Arch Section, Size Small

Class I
Calf Pad & Strap Kit, Size Small-Medium-Large (Old Xtern)

Class I
Xtern Classic Foot Drop Orthotic, Size Pediatric

Class I
Frontier Shin/Calf Pad, Magnet Strap Kit, Small-Med.-Large

Class I

See all devices from Turbomed Orthotics inc. →