EU → North America Device Access

G21 S.R.L.

IT-MF-000030085 · Italy · San Possidonio

G21 S.R.L. is registered in the European database on medical devices as a manufacturer, with 71 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa33
Class IIb30
Class I8

Most frequent device types declared: G1, SpaceFlex Knee.

Among these devices, 67 are declared sterile, 38 implantable, 4 reusable.

Devices declared under this manufacturer

Showing 12 of 71 declared devices.

Catalogue references include 900027, 900103, G210.00.004, G210.00.011, G210.00.013, G210.00.020.

European nomenclature codes declared: P099001, P09010403, K010302, P090805, P099002, P090908.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED71
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN71
Found in the U.S. device database38
Share53.5 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. G21 S.R.L. was not found in either the U.S. or the Canadian register.

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