EU → North America Device Access

Fapomed- Dispositivos Médicos, S.A.

PT-MF-000004129 · Portugal · Felgueiras

Fapomed- Dispositivos Médicos, S.A. is registered in the European database on medical devices as a manufacturer, with 354 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa354

Most frequent device types declared: Clean Air Suit, Equipment Cover (Reinforced Instrument cover), Shoe Covers, Surgical Drape (Anesthesia), Surgical Drape (Cardiovascular).

Among these devices, 351 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 354 declared devices.

Catalogue references include 111404, 113.111.000, 313138, 313153, 313173, 313180.

European nomenclature codes declared: T020199, T020102, T020401, T020402, T030101, T030199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED354
Country of registrationPortugal

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

Device-level evidence

Devices with a numeric GTIN354
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. Fapomed- Dispositivos Médicos, S.A. was not found in either the U.S. or the Canadian register.

Other manufacturers in Portugal

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