Identity
- Trade Name
- LeanOnMe EUDAMED
- Device Name
- LeanOnMe EUDAMED
- Model / Reference
- Positioning Cushions EUDAMEDIM5400SNS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708012558629 EUDAMED
- Basic UDI-DI
- 57080128001N3 EUDAMED
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
LeanOnMe by Etac Immedia A/S — 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 | 57080128001N3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Etac Immedia A/S
- EUDAMED SRN
- DK-MF-000019241
Sources (1)
- EUDAMED 85cefed9-99ae-468c-869c-3953e21904c8 61 fields · synced Jun 18, 2026