Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dres…

FDA 510(k)EUDAMED

U (US FDA 510(k))

510(k) K191819

Identifiers

510(k) Number: K191819 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)

Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dres… by Winner Medical Co., Ltd. — U — MDR, FDA_510K — listed in FDA 510(k), EUDAMED

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	U	Active
FDA 510(k)	United States	FDA_510K	K191819	U	Active

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Manufacturer

Manufacturer: Winner Medical Co., Ltd.

Sources (2)

FDA 510(k) K191819 24 fields · synced Jun 20, 2026
EUDAMED 1 fields · synced May 18, 2026