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Smartgel
EUDAMEDClass I (EU MDR)
Ref 63ASAEFL43Model Assento de Prevenção de Úlceras por Pressão
Identity
- Trade Name
- Smartgel EUDAMED
- Device Name
- Smartgel EUDAMED
- Model / Reference
- Assento de Prevenção de Úlceras por Pressão EUDAMED63ASAEFL43 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05600456981448 EUDAMED
- Basic UDI-DI
- 56004569SMARTGEL7L EUDAMED
- Direct Marketing DI
- 05600456981448 EUDAMED
- EMDN Code
- V08030102 NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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
Smartgel by Orthos XXI, Unipessoal Lda — 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 | 56004569SMARTGEL7L | Class I | Active |
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Manufacturer
- Manufacturer
- Orthos XXI, Unipessoal Lda
- EUDAMED SRN
- PT-MF-000002787
Sources (1)
- EUDAMED 20f9dd59-6080-4f52-b068-efbb4c19b2e3 61 fields · synced Oct 6, 2026