Identity
- Trade Name
- FERULA STACK DISTAL EUDAMEDFERULA STACK EUDAMED
- Device Name
- FERULA STACK PROXIMAL EUDAMEDFERULA STACK DISTAL EUDAMED
- Model / Reference
- X-5012- EUDAMEDX-5010- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08431184501205 EUDAMED08431184501007 EUDAMED
- Basic UDI-DI
- 8431184X5012Q4 EUDAMED8431184X5010PY EUDAMED
- EMDN Code
- Y061803 PARTIAL HAND PROSTHESES (INCLUDING FINGERS PROSTHESES) 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
Ferula Stack Distal by Ortoiberica S.L. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 8431184X5012Q4 | Class I | Active |
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Manufacturer
- Manufacturer
- Ortoiberica S.L.
- EUDAMED SRN
- ES-MF-000025780
Sources (2)
- EUDAMED ab1f34ce-440c-4d75-9760-0fbe2ecd1d85 61 fields · synced Jul 30, 2026
- EUDAMED 07b2356a-8dba-4857-81c7-c056644104e4 61 fields · synced May 18, 2026