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LeanOnMe
EUDAMEDClass I (EU MDR)
Ref IM5380LNSModel Positioning CushionsRef IM53XSNSRef IM53SNSRef IM15100Ref IM54SNSRef IM5300SSTRef IM16100Ref IM53SSTRef IM15106Ref IM5380LSTRef IM530080LNSRef IM15102Ref IM16101Ref IM16102Ref IM15105Ref IM5300XSNSRef IM5400SSTRef IM15103Ref IM16107Ref IM15101Ref IM5300SNSRef IM16108
Identity
- Trade Name
- LeanOnMe EUDAMED
- Device Name
- LeanOnMe EUDAMED
- Model / Reference
- Positioning Cushions EUDAMEDIM5380LNS EUDAMEDIM53XSNS EUDAMEDIM53SNS EUDAMEDIM15100 EUDAMEDIM54SNS EUDAMEDIM5300SST EUDAMEDIM16100 EUDAMEDIM53SST EUDAMEDIM15106 EUDAMEDIM5380LST EUDAMEDIM530080LNS EUDAMEDIM15102 EUDAMEDIM16101 EUDAMEDIM16102 EUDAMEDIM15105 EUDAMEDIM5300XSNS EUDAMEDIM5400SST EUDAMEDIM15103 EUDAMEDIM16107 EUDAMEDIM15101 EUDAMEDIM5300SNS EUDAMEDIM16108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708012559442 EUDAMED05708012558612 EUDAMED05708012559510 EUDAMED05708012004935 EUDAMED05708012558643 EUDAMED05708012558698 EUDAMED05708012005062 EUDAMED05708012558728 EUDAMED05708012004997 EUDAMED05708012559329 EUDAMED05708012559466 EUDAMED05708012004959 EUDAMED05708012005079 EUDAMED05708012005086 EUDAMED05708012004980 EUDAMED05708012558605 EUDAMED05708012558742 EUDAMED05708012004966 EUDAMED05708012005130 EUDAMED05708012004942 EUDAMED05708012559459 EUDAMED05708012005147 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 |
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Manufacturer
- Manufacturer
- Etac Immedia A/S
- EUDAMED SRN
- DK-MF-000019241
Sources (22)
- EUDAMED 183212ec-3dea-4cf0-8a62-620ae6f96d50 61 fields · synced Aug 1, 2026
- EUDAMED 953e04cf-1b25-47be-9d8c-371d2b38eae5 61 fields · synced May 11, 2026
- EUDAMED 2b5a6518-3bfd-46c3-b001-df63f0b72c4c 61 fields · synced May 16, 2026
- EUDAMED f9e9455a-20ec-4398-85a6-24e49c61a101 61 fields · synced May 16, 2026
- EUDAMED c563de7f-6243-4b84-8206-6c6110f89b4c 61 fields · synced May 17, 2026
- EUDAMED ee1cad63-a53b-4fc0-9525-a19fbfc8d84f 61 fields · synced May 17, 2026
- EUDAMED cfb3c3d1-a4c6-48ac-83d3-b341ba406d17 61 fields · synced May 17, 2026
- EUDAMED b1795ca8-8205-4eaa-b1f3-daeebdcc1888 61 fields · synced May 17, 2026
- EUDAMED 30956937-cdcc-4a07-ac63-6594ed327ba7 61 fields · synced May 18, 2026
- EUDAMED 60e0dbeb-f0e2-4433-83fc-7570205233f9 61 fields · synced May 18, 2026
- EUDAMED 8c6a91d2-c95c-4703-873b-f9087ae8de01 61 fields · synced May 18, 2026
- EUDAMED 8d82e6ec-d9ba-4b07-a959-d3dcf7304e47 61 fields · synced May 18, 2026
- EUDAMED c0bf3f03-a95e-4921-aa27-1a7dbebb60eb 61 fields · synced May 18, 2026
- EUDAMED 830d3d2b-b3ad-4d28-8f75-bbe7eb1302c9 61 fields · synced May 18, 2026
- EUDAMED 6ee8ce46-c589-4c02-8dd0-a431c5614829 61 fields · synced May 18, 2026
- EUDAMED e9b0d489-7f27-4e36-be5a-1382fa8bff0f 61 fields · synced May 18, 2026
- EUDAMED d18cebad-03fe-4584-87a7-be73c21832fa 61 fields · synced May 18, 2026
- EUDAMED f08804e0-8d30-4f0c-a58a-93eba7a4d725 61 fields · synced May 19, 2026
- EUDAMED 06e41e07-1e2d-49f2-bfb5-47d78815f90a 61 fields · synced May 19, 2026
- EUDAMED c2e64f55-646d-4786-a904-87e0dc0a3d8a 61 fields · synced May 19, 2026
- EUDAMED ed33a73d-2484-4a47-85c3-8c371a8d778d 61 fields · synced May 19, 2026
- EUDAMED 9be01244-0d0e-41df-bac5-9661a20ba809 61 fields · synced May 19, 2026