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Ortesis de Abducción de Pulgar ESSENCIAL XL
EUDAMEDClass I (EU MDR)
Ref C400 XL
by Prim, S.a.
Identity
- Trade Name
- Ortesis de Abducción de Pulgar ESSENCIAL XL EUDAMED
- Device Name
- Ortesis de Mano, Muñeca y/o Dedos EUDAMED
- Model / Reference
- C400 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048122134 EUDAMED
- Basic UDI-DI
- 843404825ORTESISMANOSXD EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS 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 de Abducción de Pulgar ESSENCIAL XL 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 | 843404825ORTESISMANOSXD | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (2)
- EUDAMED 5626cdea-6277-478d-b2aa-7d1820a1c6b3 61 fields · synced Jul 9, 2026
- EUDAMED 546b953a-8ae6-4c3b-a68e-4a7929084b27 61 fields · synced Jul 9, 2026