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SWASH Classic Set Barras 115° 1
EUDAMEDClass I (EU MDR)
Ref OC101A
by Prim, S.a.
Identity
- Trade Name
- SWASH Classic Set Barras 115° 1 EUDAMED
- Device Name
- Ortesis de Cadera EUDAMED
- Model / Reference
- OC101A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680711173 EUDAMED
- Basic UDI-DI
- 843404825ORTESISCADERAYT EUDAMED
- EMDN Code
- Y061215 HIP ORTHOSES (INCLUDING ABDUCTION 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
SWASH Classic Set Barras 115° 1 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 | 843404825ORTESISCADERAYT | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (1)
- EUDAMED 662243ea-198d-4809-b054-51a6bbb5522f 61 fields · synced Jul 29, 2026