EU → North America Device Access

BODE Chemie GmbH

DE-MF-000005851 · Germany · Hamburg

BODE Chemie GmbH is registered in the European database on medical devices as a manufacturer, with 104 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa87
Class IIb17

Most frequent device types declared: 2658, 2718, 2723, 2759, 3775.

Devices declared under this manufacturer

Showing 12 of 104 declared devices.

Catalogue references include 975386, 975395, 975670, 981246, 981462, 981579.

European nomenclature codes declared: D99, D0799, D0701, D01010102, A99, V0799.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED104
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN104
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. BODE Chemie GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
0523GB448251013issued2030-11-12

Other manufacturers in Germany

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