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Art. Rodilla Monocentrica Black 1045
EUDAMEDClass I (EU MDR)
Ref P-1045-000Model P-1045
Identity
- Trade Name
- ART. RODILLA MONOCENTRICA BLACK 1045 EUDAMED
- Device Name
- ART. RODILLA MONOCENTRICA BLACK 1045 EUDAMED
- Model / Reference
- P-1045 EUDAMEDP-1045-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08431184104505 EUDAMED
- Basic UDI-DI
- 8431184P1045000WD EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER 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 Monocentrica Black 1045 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 | 8431184P1045000WD | Class I | Active |
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Manufacturer
- Manufacturer
- Ortoiberica S.L.
- EUDAMED SRN
- ES-MF-000025780
Sources (1)
- EUDAMED bb559b4a-ff4b-4379-a558-947b3a59fef1 61 fields · synced Jun 18, 2026