EU → North America Device Access

Hammarplast Medical AB

SE-MF-000009420 · Sweden · Lidköping

Hammarplast Medical AB is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa15

Most frequent device types declared: Ear Speculum, HPM Roll-on cuff, Lock till medicinbägare, Medicinbägare engångs 60 ml.

Devices declared under this manufacturer

Showing 12 of 15 declared devices.

Catalogue references include 00464, 10314, 10400, 31110, 31210, 4556.

European nomenclature codes declared: V9003, A070501, Z12149085, V9017.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHAMMARPLAST MEDICAL AB (SE) · FDA 3006703573
Devices in EUDAMED15
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN15
Found in the U.S. device database0
Share0.0 %

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. Hammarplast Medical AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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