EU → US Device Access

Humeca B.V.

NL-MF-000010933 · Netherlands · Borne

Humeca B.V. is registered in the European database on medical devices as a manufacturer, with 86 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa86

Most frequent device types declared: Humeca blades for Knives.

Among these devices, 63 are declared sterile, 5 reusable, 10 active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED86
Country of registrationNetherlands
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
2269201CE01issued2031-08-01

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