EU → North America Device Access

Solventum Germany GmbH

DE-MF-000038373 · Germany · Kamen

Solventum Germany GmbH is registered in the European database on medical devices as a manufacturer, with 215 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb52
Class IIa163

Most frequent device types declared: Solventum™ Micropore™ Surgical Tape.

Among these devices, 83 are declared sterile, 21 implantable, 7 active.

Devices declared under this manufacturer

Showing 12 of 215 declared devices.

Catalogue references include 1530P-0D, 2991P-2, 3566SP, 3569NP, 3573E, 56660.

European nomenclature codes declared: M050101, M040204, M03050202, M04010101, Q01010106, M040404.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySolventum Germany GmbH (DE) · FDA 9611385
Devices in EUDAMED215
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN215
Found in the U.S. device database44
Share20.5 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entrySOLVENTUM GERMANY GMBH

What it holds in Canada

Licences on record15
Currently active0
Class 2 devices10
Class 3 devices4
Class 4 devices1
First licensed1999-03-05

Licence types: Device Family (10), Device Group Family (3), Single Device (2).

Licensed under: PHOTAC-FIL QUICK APLICAP, TOOTH BONDING RESIN, RELYX TEMP NE, DURELON, TEGADERM HIGH PERFORMANCE FOAM NON-ADHESIVE DR, PROMOGRAN COLLAGEN MATRIX WITH ORC.

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

Other manufacturers in Germany

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