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SWASH Steady Banda Pélvica
EUDAMEDClass I (EU MDR)
Ref SC3 100 3Ref SC3 100 1Ref SC3 100 4
by Prim, S.a.
Identity
- Trade Name
- SWASH Steady Banda Pélvica EUDAMED
- Device Name
- Ortesis de Cadera EUDAMED
- Model / Reference
- SC3 100 3 EUDAMEDSC3 100 1 EUDAMEDSC3 100 4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048083312 EUDAMED08434048083299 EUDAMED08434048083329 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 Steady Banda Pélvica 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 (6)
- EUDAMED fdfda191-b684-4629-8db2-a31c2fb144c3 61 fields · synced Jul 9, 2026
- EUDAMED 8471f233-1aa9-49be-9691-7c9170d5778f 61 fields · synced May 17, 2026
- EUDAMED aea8dab7-078d-49d3-8f0a-da14e1231ef9 61 fields · synced May 18, 2026
- EUDAMED d5f4bb1c-a024-4740-ad64-9056fa8ec465 61 fields · synced Jun 11, 2026
- EUDAMED d40ebf28-b05b-45d5-8ae7-0775f1f6960d 61 fields · synced Jul 9, 2026
- EUDAMED fe24c3c5-c4da-49fd-ab66-d17349ceb10b 61 fields · synced Jul 9, 2026