EU → North America Device Access

Nippon Gases España S.L.U.

ES-MF-000004323 · Spain · Madrid

Nippon Gases España S.L.U. 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

Most frequent device types declared: GARP3, GARPS, GDCP2, GDCP5, GDCPS.

Devices declared under this manufacturer

Showing 12 of 138 declared devices.

Catalogue references include 10H, 10H/300, 50HH/185, 5HA, LE-LD10, PGS196.

European nomenclature codes declared: V0901, V0902, V0999, V0905, V0904.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED138
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 GTIN138
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. Nippon Gases España S.L.U. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2025 CR 0058issued2030-08-11

Other manufacturers in Spain

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