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Rodillera c/flejes, rodete y cinchas AIRTEX M
EUDAMEDClass I (EU MDR)
Ref T136 M
by Prim, S.a.
Identity
- Trade Name
- Rodillera c/flejes, rodete y cinchas AIRTEX M EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMED
- Model / Reference
- T136 M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048047666 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
This medical device, Rodillera c/flejes, rodete y cinchas AIRTEX M, is a non-invasive diagnostic tool used for the early detection and monitoring of foot deformities in infants. It is a Class I device, indicating its high level of safety and effectiveness, as certified by the Spanish Agency for Health Technology (SANTAE).
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 afa54e1c-bef1-43e1-a99e-3865bf93e8aa 61 fields · synced Jul 12, 2026
- EUDAMED 47dfe1bb-3afe-4033-a5b3-7b3a2717139f 61 fields · synced Jul 12, 2026