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Ortesis TLSO PRIMSPINE FOCUS
EUDAMEDClass I (EU MDR)
Ref PRS666 LRef PRS666 XXLRef PRS666 M
by Prim, S.a.
Identity
- Trade Name
- Ortesis TLSO PRIMSPINE FOCUS EUDAMED
- Device Name
- ORTESIS DE COLUMNA:CORSÉS EUDAMED
- Model / Reference
- PRS666 L EUDAMEDPRS666 XXL EUDAMEDPRS666 M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048385157 EUDAMED08434048545421 EUDAMED08434048385140 EUDAMED
- Basic UDI-DI
- 843404825CORSECX EUDAMED
- EMDN Code
- Y060309 THORACOLUMBOSACRAL SPINE 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
Ortesis TLSO PRIMSPINE FOCUS 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 | 843404825CORSECX | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (3)
- EUDAMED c3016872-cf97-4370-a556-7587c782f615 61 fields · synced Aug 1, 2026
- EUDAMED f97abcda-1a5c-4fa7-966e-81a8653adc55 61 fields · synced May 18, 2026
- EUDAMED 32221351-6f2f-40e6-ac29-7be22a84daca 61 fields · synced May 18, 2026