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Rodillera ROM AIRTEX
EUDAMEDClass I (EU MDR)
Ref ATX730 SRef ATX730 M
by Prim, S.a.
Identity
- Trade Name
- Rodillera ROM AIRTEX EUDAMEDRodillera ROM AIRTEX M EUDAMEDRodillera ROM AIRTEX S EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMED
- Model / Reference
- ATX730 S EUDAMEDATX730 M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048476916 EUDAMED08434048476923 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 AIRTEX 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 (4)
- EUDAMED 28833ab8-f61d-499a-b064-a1c8466aef3d 61 fields · synced Sep 18, 2026
- EUDAMED 9c5a36ff-64f8-463c-9974-4358c5ede5b6 61 fields · synced May 18, 2026
- EUDAMED 0dc1ca1c-56e8-4ada-9468-df58f6dc4050 61 fields · synced Jun 11, 2026
- EUDAMED 3a5c701e-2f92-4f6e-8a1e-72281e408d62 61 fields · synced Sep 18, 2026