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Orkla Wound Care AB

SE-MF-000021041 · Sweden · Solna

Orkla Wound Care AB is registered in the European database on medical devices as a manufacturer, with 138 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa138

Among these devices, 18 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 138 declared devices.

Catalogue references include 451143001, 510001686, 510001713, 510001722, 51011022, 51011042.

European nomenclature codes declared: M0599, M04010199, M04040501, M0303010203, M04040101, M04010102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED138
Country of registrationSweden

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN138
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryORKLA WOUND CARE AB

North American profile: Canada only. Orkla Wound Care AB holds a Canadian licence but was not found in the U.S. register.

Notified body certificates

CertificateStatusExpiry
28620123341-02issued2027-02-07

Other manufacturers in Sweden

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