EU → North America Device Access

seca gmbh & co. kg

DE-MF-000005469 · Germany · Hamburg

seca gmbh & co. kg is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5

Most frequent device types declared: ACLMI001memf, MDSW001.

Among these devices, 1 are declared active, 4 with a measuring function.

Devices declared under this manufacturer

Catalogue references include 1252000040, 2201714003, 2201814003, 2231717998, 2231814998.

European nomenclature codes declared: V030209, Z12040192.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySECA (DE) · FDA 3003587684
Devices in EUDAMED5
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database2
Share40.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entrySECA GMBH & CO. KG

What it holds in Canada

Licences on record6
Currently active0
Class 2 devices6
First licensed2016-07-19

Licence types: Single Device (3), Device Family (2), System (1).

Licensed under: MEASURING STATION (SECA 286), SECA ANALYTICS 125, SECA MBCA 554, SECA BIA-HANDRAIL/SECA BIA-HANDLE, SECA 257, SECA MBCA 525 C.

North American profile: Both markets. seca gmbh & co. kg is registered in both the United States and Canada.

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