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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.

Devices declared under this manufacturer

Showing 12 of 86 declared devices.

Catalogue references include 2.4/40, 2.6/405p, 2.9/10, 4.HMB, 5.BLHCW10, 5.BLPG/1.

European nomenclature codes declared: V010302, M0299, V901699, L0103, L2403, S010401.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED86
Country of registrationNetherlands

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

Device-level evidence

Devices with a numeric GTIN86
Found in the U.S. device database76
Share88.4 %
⚠ 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 listingLicensed in Canada
Matched entryHUMECA B.V.

North American profile: Canada only. Humeca B.V. holds a Canadian licence but was not found in the U.S. register.

Notified body certificates

CertificateStatusExpiry
2269201CE01issued2031-08-01

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