Identity
- Trade Name
- MEDIA TIBIAL T/GL-PAR- EUDAMED
- Device Name
- MEDIA TIBIAL / FEMORAL EUDAMED
- Model / Reference
- P-0068- EUDAMEDP-0068-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08431184006830 EUDAMED
- Basic UDI-DI
- 8431184P00680052 EUDAMED
- EMDN Code
- Y062409 TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Media Tibial T/Gl-Par- by Ortoiberica S.L. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Mechanical-resistance external ankle-foot prosthesis.
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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 | 8431184P00680052 | Class I | Active |
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Manufacturer
- Manufacturer
- Ortoiberica S.L.
- EUDAMED SRN
- ES-MF-000025780
Sources (1)
- EUDAMED abf9fda9-156e-46d4-9885-f64ea0b70c64 61 fields · synced Jul 30, 2026