EU → North America Device Access

H. + H. Maslanka Chirurgische Instrumente GmbH

DE-MF-000005600 · Germany · Tuttlingen

H. + H. Maslanka Chirurgische Instrumente GmbH is registered in the European database on medical devices as a manufacturer, with 147 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa147

Among these devices, 3 are declared sterile, 137 reusable, 9 active.

Devices declared under this manufacturer

Showing 12 of 147 declared devices.

Catalogue references include 106.424, 108.724, 116.418, 116.518, 304.726, 316.726.

European nomenclature codes declared: G0305010201, V070101, L181003, G030804, W0202029099.

United States market access

FDA establishment registerRegistered with FDA
Matched entryH.+H. Maslanka Chirurgische Instrumente GmbH (DE) · FDA 3008808042
Devices in EUDAMED147
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN147
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryH.+ H. MASLANKA CHIRURGISCHE INSTRUMENTE GMBH

What it holds in Canada

Licences on record1
Currently active0
Class 2 devices1
First licensed2017-05-29

Licence types: Device Family (1).

Licensed under: FLEX-PUSHER II.

North American profile: Both markets. H. + H. Maslanka Chirurgische Instrumente GmbH is registered in both the United States and Canada.

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