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Rodillera Suspensión Neo-Flex
EUDAMEDClass I (EU MDR)
Ref P-5400-Ref P-5400-001
Identity
- Trade Name
- RODILLERA SUSPENSIÓN NEO-FLEX EUDAMEDRODILLERA SUSPENSION NEO-FLEX T/1 EUDAMED
- Device Name
- RODILLERA SUSPENSIÓN NEO-FLEX EUDAMED
- Model / Reference
- P-5400- EUDAMEDP-5400-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08431184054008 EUDAMED08431184540013 EUDAMED
- Basic UDI-DI
- 8431184P5400MR 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 Suspensión Neo-Flex 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 | 8431184P5400MR | Class I | Active |
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Manufacturer
- Manufacturer
- Ortoiberica S.L.
- EUDAMED SRN
- ES-MF-000025780
Sources (2)
- EUDAMED 15a6d0c2-9fa6-4606-8ba8-05321752c227 61 fields · synced Jul 20, 2026
- EUDAMED 2eb33816-7b57-4122-ad4a-5f57f384db08 61 fields · synced May 18, 2026