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Fluffy Seat
EUDAMEDClass I (EU MDR)
Ref 63ASAEPSQDModel Assento de Prevenção de Úlceras por Pressão
Identity
- Trade Name
- Fluffy Seat EUDAMED
- Device Name
- Fluffy Seat EUDAMED
- Model / Reference
- Assento de Prevenção de Úlceras por Pressão EUDAMED63ASAEPSQD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05600456980458 EUDAMED
- Basic UDI-DI
- 56004569FLUFFYSEATA5 EUDAMED
- Direct Marketing DI
- 05600456980458 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
Fluffy Seat 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 | 56004569FLUFFYSEATA5 | Class I | Active |
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Manufacturer
- Manufacturer
- Orthos XXI, Unipessoal Lda
- EUDAMED SRN
- PT-MF-000002787
Sources (1)
- EUDAMED 49b228ab-80ae-4f5a-9af5-9d0b5fe3244b 61 fields · synced Oct 6, 2026