Identity
- Trade Name
- Rodillera ROM E-SENSE EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMED
- Model / Reference
- RS-3000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048088171 EUDAMED
- Basic UDI-DI
- 843404825ORTESISRODILLASD EUDAMED
- EMDN Code
- Y061209 KNEE 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
Rodillera ROM E-SENSE by Prim S.a. — 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 | 843404825ORTESISRODILLASD | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (2)
- EUDAMED 8b88af4c-5ea1-4c21-9322-7fe84c959fcb 61 fields · synced Jul 8, 2026
- EUDAMED a5cd8139-7417-416c-b286-12fb24f7de13 61 fields · synced Jun 18, 2026