Copper Foam Dressing (Prescription and OTC)

FDA 510(k)EUDAMED

U (US FDA 510(k))

510(k) K231088

Identifiers

510(k) Number: K231088 FDA 510(k)
FDA Product Code: FRO FDA 510(k)

Classification

Device Class: U FDA 510(k)
Advisory Committee: Unknown FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Copper Foam Dressing (Prescription and OTC) by Roosin Medical Co., Ltd. — U — MDD, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	U	Active
FDA 510(k)	United States	FDA_510K	K231088	U	Active

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Manufacturer

Manufacturer: Roosin Medical Co., Ltd.

Sources (2)

FDA 510(k) K231088 24 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced May 19, 2026