EU → North America Device Access

Wipak Oy

FI-MF-000004496 · Finland · Nastola

Wipak Oy is registered in the European database on medical devices as a manufacturer, with 402 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa402

Devices declared under this manufacturer

Showing 12 of 402 declared devices.

Catalogue references include LTS1530, NWG130/150, PB7, R43/31; R43-3P/31, S18-D, S24; S24-3P.

European nomenclature codes declared: S010302, S01010101, S01020101, S010301, S010199, S01010201.

United States market access

FDA establishment registerRegistered with FDA
Matched entryWIPAK OY (FI) · FDA 9613277
Devices in EUDAMED402
Country of registrationFinland

Device-level evidence

Devices with a numeric GTIN402
Found in the U.S. device database104
Share25.9 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. Wipak Oy is registered in the United States but was not found in the Canadian register.

Other manufacturers in Finland

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