EU → North America Device Access

VacuTec Meßtechnik GmbH

DE-MF-000006432 · Germany · Dresden

VacuTec Meßtechnik GmbH is registered in the European database on medical devices as a manufacturer, with 58 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa46
Class IIb12

Most frequent device types declared: VacuDAP - OEM, VacuDAP - OEM duo, VacuDAP 2004 OEM, VacuDAP Bluetooth, VacuDAP compact.

Among these devices, 58 are declared active, 46 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 58 declared devices.

Catalogue references include 142 00 13, 145 00 97, 151 00 21, 156 00 05, 156 00 18, 158 00 12.

European nomenclature codes declared: Z11039099, Z11039080.

United States market access

FDA establishment registerRegistered with FDA
Matched entryVACUTEC MESSTECHNIK GMBH (DE) · FDA 3003920322
Devices in EUDAMED58
Country of registrationGermany

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: United States only. VacuTec Meßtechnik GmbH is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
HZ 1170821-1supplemented2030-06-25

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