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Wound dressings with copper oxide

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 2C-0506-01510(k) K180643Ref 2C-1025-01aModel 2C-1025-01a

by MedCu Technologies

Identity

Device Name
Wound dressings with copper oxide EUDAMED
Model / Reference
2C-0506-01 EUDAMED
2C-1025-01a EUDAMED

Identifiers

Primary DI / UDI-DI
07290018406168 EUDAMED
07290018406175 EUDAMED
Basic UDI-DI
B-07290018406168 EUDAMED
B-07290018406175 EUDAMED
510(k) Number
K180643 FDA 510(k)
FDA Product Code
FRO FDA 510(k)
EMDN Code
M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMED

Classification

Device Class
Class IIa EUDAMED
U FDA 510(k)
Market of Registration
Austria EUDAMED
Advisory Committee
Unknown FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Wound dressings with copper oxide by MedCu Technologies — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
MedCu Technologies
EUDAMED SRN
IL-MF-000011516
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (4)

  • EUDAMED 229bc59e-9694-4e0b-bdaa-731e250ab9c1 61 fields · synced Jul 20, 2026
  • FDA 510(k) K180643 24 fields · synced May 18, 2026
  • EUDAMED 08a4356c-3e61-48ba-9bc7-b0d183f1bd10 61 fields · synced Jul 10, 2026
  • EUDAMED e1f2bc24-6ea6-4392-bcaf-0370b9bac902 61 fields · synced Jul 20, 2026