Identity
- Trade Name
- ART. RODILLA HIDRAULICA BLACK 1028 EUDAMED
- Device Name
- ART. RODILLA HIDRAULICA BLACK 1028 EUDAMED
- Model / Reference
- P-1028-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08431184102808 EUDAMED
- Basic UDI-DI
- 8431184P1028000WC EUDAMED
- EMDN Code
- Y06121203 ACTIVE KNEE-ANKLE-FOOT ORTHOSES 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
Art. Rodilla Hidraulica Black 1028 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 | 8431184P1028000WC | Class I | Active |
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Manufacturer
- Manufacturer
- Ortoiberica S.L.
- EUDAMED SRN
- ES-MF-000025780
Sources (1)
- EUDAMED bd3b6270-3393-44ba-83a1-1ebf79182365 61 fields · synced Jul 12, 2026