EU → North America Device Access

northh medical GmbH

DE-MF-000005858 · Germany · Hamburg

northh medical GmbH 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: P01-SB-01.

Among these devices, 5 are declared active, 5 with a measuring function.

Devices declared under this manufacturer

Catalogue references include P01-SB-01, P01-SB-01 (Lot 05), P01-SB-01 (Lot 06), P01-SB-01-03.

European nomenclature codes declared: Z1104018099, Z1105018099.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNORTHH MEDICAL GMBH (DE) · FDA 3019595609
Devices in EUDAMED5
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database4
Share80.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryNORTHH MEDICAL GMBH

What it holds in Canada

Licences on record1
Currently active0
Class 2 devices1
First licensed2024-06-26

Licence types: System (1).

Licensed under: SMART-SYNC.

North American profile: Both markets. northh medical GmbH is registered in both the United States and Canada.

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