Identity
- Trade Name
- PEPE - Dispositivo de Rotación de Paciente EUDAMED
- Device Name
- KMINA and PEPE Home and hygiene assistive products EUDAMED
- Model / Reference
- P40013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436584362418 EUDAMED
- Basic UDI-DI
- 436584K40000AEL EUDAMED
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS 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
PEPE - Dispositivo de Rotación de Paciente by Improving Mobility Development SL — 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 | 436584K40000AEL | Class I | Active |
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Manufacturer
- Manufacturer
- Improving Mobility Development SL
- EUDAMED SRN
- ES-MF-000010985
Sources (1)
- EUDAMED 64c3fb53-330e-460a-aa68-6a8e282fdba6 61 fields · synced Jul 25, 2026