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Soft-Touch Cover
EUDAMEDClass I (EU MDR)
Ref IM10508Model Positioning CushionsRef IM10500Ref IM10513Ref IM10507Ref IM10501Ref IM10505Ref IM10502Ref IM10504
Identity
- Trade Name
- Soft-Touch Cover EUDAMED
- Device Name
- LeanOnMe EUDAMED
- Model / Reference
- Positioning Cushions EUDAMEDIM10508 EUDAMEDIM10500 EUDAMEDIM10513 EUDAMEDIM10507 EUDAMEDIM10501 EUDAMEDIM10505 EUDAMEDIM10502 EUDAMEDIM10504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708012004027 EUDAMED05708012003952 EUDAMED05708012004072 EUDAMED05708012004089 EUDAMED05708012003969 EUDAMED05708012004003 EUDAMED05708012003976 EUDAMED05708012003990 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
Soft-Touch Cover 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 |
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Manufacturer
- Manufacturer
- Etac Immedia A/S
- EUDAMED SRN
- DK-MF-000019241
Sources (8)
- EUDAMED 2614da33-6b69-495c-9b78-4eb3d8faa039 61 fields · synced Oct 1, 2026
- EUDAMED e1ea4f04-fb15-43e4-a943-4a83282cf74d 61 fields · synced May 17, 2026
- EUDAMED 4308df62-63d3-4079-babb-fd40dfd7e568 61 fields · synced May 17, 2026
- EUDAMED 0e5d124c-1c48-498b-b0b1-11772be81b03 61 fields · synced May 17, 2026
- EUDAMED 74589e36-789f-4926-b209-9c3e796190d8 61 fields · synced May 18, 2026
- EUDAMED 6278603e-14ff-4ce2-bd76-0b3eed6abaab 61 fields · synced May 18, 2026
- EUDAMED 703be01e-4555-41de-a989-3f1216b72e58 61 fields · synced May 18, 2026
- EUDAMED 8902c2bf-c6ca-453c-ac4e-4c5da1cd8406 61 fields · synced May 18, 2026