EU → North America Device Access

RZ-Medizintechnik GmbH

DE-MF-000005616 · Germany · Tuttlingen

RZ-Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 187 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa187

Among these devices, 187 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 187 declared devices.

Catalogue references include 225-019-030, 225-127-030, 252-127-200, 253-804-400, 253-829-012, 253-910-540.

European nomenclature codes declared: Z12029009, Z12020701, Z12021101, Z12021008, Z12020704, Z12020903.

United States market access

FDA establishment registerRegistered with FDA
Matched entryRZ MEDIZINTECHNIK GMBH (DE) · FDA 9680718
Devices in EUDAMED187
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN187
Found in the U.S. device database25
Share13.4 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryRZ MEDIZINTECHNIK GMBH

What it holds in Canada

Licences on record27
Currently active0
Class 2 devices27
First licensed2001-08-14

Licence types: Device Family (27).

Licensed under: HAEMORRHOIDAL LIGATOR, SUCTION AND IRRIGATION CANNULA, ELECTROSURGICAL ELECTRODE, CYSTOSCOPES, RESECTOSCOPES, HYSTEROSCOPIES.

North American profile: Both markets. RZ-Medizintechnik GmbH is registered in both the United States and Canada.

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