Identity
- Trade Name
- Proprio Foot® EUDAMED
- Model / Reference
- BU00048 EUDAMEDPSX01127LBR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05690967920920 EUDAMED
- Basic UDI-DI
- 5690967BU00048NM EUDAMED
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Mechanical-resistance external ankle-foot prosthesis
Proprio Foot® by Össur Iceland ehf. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical-resistance external ankle-foot prosthesis.
- TruStep — COLLEGE PARK INDUSTRIES, INC. · Class I
- Tribute — COLLEGE PARK INDUSTRIES, INC. · Class I
- Venture — COLLEGE PARK INDUSTRIES, INC. · Class I
- Aviator — COLLEGE PARK INDUSTRIES, INC. · Class I
- Soleus — COLLEGE PARK INDUSTRIES, INC. · Class I
- Onyx — COLLEGE PARK INDUSTRIES, INC. · Class I
- TruStep — COLLEGE PARK INDUSTRIES, INC. · Class I
- Soleus — COLLEGE PARK INDUSTRIES, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5690967BU00048NM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Össur Iceland ehf.
- EUDAMED SRN
- IS-MF-000000173
Sources (1)
- EUDAMED c707dac8-e217-4f23-8c41-635bce1b104a 61 fields · synced Jun 11, 2026