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Botín Cazoleta de Sarmiento
EUDAMEDClass I (EU MDR)
Ref H1 SRRef H2 MRRef H1 LLRef H2 SLRef H2 MLRef H2 LRRef H1 MR
by Prim, S.a.
Identity
- Trade Name
- Botín Cazoleta de Sarmiento EUDAMED
- Device Name
- Ortesis Tibiales EUDAMED
- Model / Reference
- H1 SR EUDAMEDH2 MR EUDAMEDH1 LL EUDAMEDH2 SL EUDAMEDH2 ML EUDAMEDH2 LR EUDAMEDH1 MR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680629140 EUDAMED08426680629232 EUDAMED08426680629171 EUDAMED08426680629126 EUDAMED08426680629249 EUDAMED08426680629256 EUDAMED08426680629225 EUDAMED
- Basic UDI-DI
- 843404825ORTESISTIBIAXY EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER 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
Botín Cazoleta de Sarmiento 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 | 843404825ORTESISTIBIAXY | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (7)
- EUDAMED d2b0830a-2dcf-4614-97cb-a024c911edc2 61 fields · synced Sep 17, 2026
- EUDAMED 75612c56-9a20-4f0f-adc4-9fdd983396a9 61 fields · synced May 16, 2026
- EUDAMED e67bf37a-395f-4f51-9bcb-2e06b423f2ff 61 fields · synced May 17, 2026
- EUDAMED da040350-21a2-4aeb-ae9e-c36c6a012c25 61 fields · synced May 18, 2026
- EUDAMED 788d4f22-ed6d-4997-9357-638fbc216595 61 fields · synced May 18, 2026
- EUDAMED 454e105e-c68c-4b8c-a1a0-7bee39489858 61 fields · synced May 18, 2026
- EUDAMED 40b36ff5-44c8-4ea9-bf1c-2d4f149f45a4 61 fields · synced May 19, 2026