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SWASH Classic Banda Pélvica
EUDAMEDClass I (EU MDR)
Ref OC107 2 Ref OC107 3 Ref OC107 4 Ref OC107 1
by Prim, S.a.
Identity
- Trade Name
- SWASH Classic Banda Pélvica EUDAMED
- Device Name
- Ortesis de Cadera EUDAMED
- Model / Reference
- OC107 2 EUDAMEDOC107 3 EUDAMEDOC107 4 EUDAMEDOC107 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680757010 EUDAMED08426680757027 EUDAMED08426680757034 EUDAMED08426680757003 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 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 (4)
- EUDAMED 2ab1ecc7-0367-4a51-bf24-975d5e63a72a 61 fields · synced Jul 24, 2026
- EUDAMED b9200c89-a74b-4b6b-b790-7cd98c1c57d7 61 fields · synced May 17, 2026
- EUDAMED 6dc12ea4-0d2e-445c-bfcc-824a62a8fd02 61 fields · synced May 17, 2026
- EUDAMED f4cd09a6-9561-4a2c-8d07-67646ae52a2c 61 fields · synced May 19, 2026