EU → North America Device Access

Hoogland Spine Products GmbH

DE-MF-000011261 · Germany · Unterfoehring

Hoogland Spine Products GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa11

Among these devices, 11 are declared reusable.

Catalogue references include 1002-TS 001, 1002-TS 002, 1002-TS 002-15, 1002-TS 003, 1002-TS 004, 1002-TS 004-15.

European nomenclature codes declared: Z12021101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHoogland Spine Products GmbH (DE) · FDA 3006561161
Devices in EUDAMED11
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN11
Found in the U.S. device database10
Share90.9 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryHOOGLAND SPINE PRODUCTS GMBH

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices3
First licensed2025-09-02

Licence types: Device Family (3).

Licensed under: DISPOSABLE MANUAL BONE DRILL, MAXMORESPINE BIPOLAR ELECTRODES, MAXMORESPINE TOM ENDO STICK.

North American profile: Both markets. Hoogland Spine Products GmbH is registered in both the United States and Canada.

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