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Talonera c/ descarga central, silicona
EUDAMEDClass I (EU MDR)
Ref P400-A S
by Prim, S.a.
Identity
- Trade Name
- Talonera c/ descarga central, silicona EUDAMED
- Device Name
- Ortesis Podológicas/Podiatry Orthoses EUDAMED
- Model / Reference
- P400-A S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048211821 EUDAMED
- Basic UDI-DI
- 843404825PRODUCTOSPIEV7 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Talonera c/ descarga central, silicona by Prim S.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 843404825PRODUCTOSPIEV7 | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (1)
- EUDAMED c97d1b96-2f3f-4f36-b55d-e5450286ed49 61 fields · synced Jul 15, 2026