Identity
- Trade Name
- MEDIA FEMORAL T/M -PAR- EUDAMED
- Device Name
- MEDIA TIBIAL / FEMORAL EUDAMED
- Model / Reference
- P-0068- EUDAMEDP-0068-103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08431184068036 EUDAMED
- Basic UDI-DI
- 8431184P00680052 EUDAMED
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE 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: Mechatronic external knee prosthesis
Media Femoral T/M -par- by Ortoiberica S.L. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 f575adbf-60ae-44ec-8310-d84bee42b5ac 61 fields · synced Jun 19, 2026