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SWASH Steady Set Banda Pélvica
EUDAMEDClass I (EU MDR)
Ref SC3 10 4 Ref SC3 10 1 Ref SC3 10 3
by Prim, S.a.
Identity
- Trade Name
- SWASH Steady Set Banda Pélvica EUDAMED
- Device Name
- Ortesis de Cadera EUDAMED
- Model / Reference
- SC3 10 4 EUDAMEDSC3 10 1 EUDAMEDSC3 10 3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048129515 EUDAMED08434048129485 EUDAMED08434048129508 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 Set 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 af6e0c42-7d0c-4aed-99b1-1c446a0bb593 61 fields · synced Aug 4, 2026
- EUDAMED 01b1ccd4-fa86-49c0-b256-0039a7029caa 61 fields · synced May 17, 2026
- EUDAMED 5945871f-5511-43a2-b0ed-e342412bc5aa 61 fields · synced May 17, 2026
- EUDAMED 2680d49b-bd49-4376-8326-02fae0578d9f 61 fields · synced Jul 10, 2026
- EUDAMED a20ca83d-2ae3-4823-9e05-2e37d347b673 61 fields · synced Jul 30, 2026
- EUDAMED c5225292-0fa3-4050-a650-33f33799b956 61 fields · synced Aug 4, 2026