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Hygienic Cover

EUDAMED

Class I (EU MDR)

Ref IM10604Model Positioning CushionsRef IM10607Ref IM10605Ref IM10611Ref IM10613Ref IM10600

by Etac Immedia A/S

Identity

Trade Name
Hygienic Cover EUDAMED
Device Name
LeanOnMe EUDAMED
Model / Reference
Positioning Cushions EUDAMED
IM10604 EUDAMED
IM10607 EUDAMED
IM10605 EUDAMED
IM10611 EUDAMED
IM10613 EUDAMED
IM10600 EUDAMED

Identifiers

Primary DI / UDI-DI
05708012004126 EUDAMED
05708012004164 EUDAMED
05708012004133 EUDAMED
05708012004188 EUDAMED
05708012004201 EUDAMED
05708012004034 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

Hygienic 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

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Manufacturer

Manufacturer
Etac Immedia A/S
EUDAMED SRN
DK-MF-000019241

Sources (6)

  • EUDAMED af8c17ec-3a67-4567-b8c5-a8ac01ce978e 61 fields · synced Sep 17, 2026
  • EUDAMED bea60a4b-f948-4468-8f66-e4d924e934cd 61 fields · synced May 16, 2026
  • EUDAMED 6be3168e-2c68-4fad-ab87-8b3c52d464b4 61 fields · synced May 16, 2026
  • EUDAMED 03ee190a-9764-4047-9715-b664a38f2fa5 61 fields · synced May 18, 2026
  • EUDAMED 0dff3503-a11b-416c-9965-a04dbe1e6bf9 61 fields · synced May 18, 2026
  • EUDAMED 06ad0038-e3c6-4ba8-8b30-c60380a2039f 61 fields · synced May 19, 2026