EU → North America Device Access

2miil artesania sanitaria sl

ES-MF-000009569 · Spain · Alpedrete, Madrid

2miil artesania sanitaria sl is registered in the European database on medical devices as a manufacturer, with 81 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa81

Most frequent device types declared: ARM, SHOULDER AND CLAVICLE IMMOBILIZER FAMILY, ENDOTRACHEAL TUBE AND TRACHEOSTOMY CANNULA FIXATION FAMILY, MOULDABLE FINGER AND FOREARM SPLINTS FAMILY, PRESSURE ULCER PREVENTION PRODUCTS FAMILY, RESTRAINT PRODUCTS FAMILY.

Devices declared under this manufacturer

Showing 12 of 81 declared devices.

Catalogue references include FI-130, FI-300, FI-400, FI-510_G, FI-520_G, PR-100F.

European nomenclature codes declared: M030501, V0804, M030504, V0811, T0207, T030599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED81
Country of registrationSpain

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

Device-level evidence

Devices with a numeric GTIN81
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: Neither register. 2miil artesania sanitaria sl was not found in either the U.S. or the Canadian register.

Other manufacturers in Spain

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