EU → North America Device Access

Möller Medical GmbH

DE-MF-000005100 · Germany · Fulda

Möller Medical GmbH is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16

Most frequent device types declared: AESTHETICS Accessories, active, AESTHETICS Accessories, not active, AESTHETICS Tube Sets, Blood Donation Sealers, Foot-switch.

Among these devices, 3 are declared sterile, 12 active.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include 00002286, 00003982, 00004249, 00004253, 00004255, 406937.

European nomenclature codes declared: Z12040214, A030105, W02029008, A03010299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
Country of registrationGermany

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

Device-level evidence

Devices with a numeric GTIN16
Found in the U.S. device database4
Share25.0 %
⚠ 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. Möller Medical GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
7295GB448260616supplemented2031-04-22

Other manufacturers in Germany

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