EU → North America Device Access

biocyc Biotechnologie GmbH & Co. KG

DE-MF-000031533 · Germany · Potsdam

biocyc Biotechnologie GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 1 226 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Devices declared under this manufacturer

Showing 12 of 1 226 declared devices.

Catalogue references include C-B003-01, C-S001-01, C-T004-05, MM-003-1000, P-C045-70, P-G001-70.

European nomenclature codes declared: W01030709, W01030711, W01030799.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 226
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 GTIN514
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. biocyc Biotechnologie GmbH & Co. KG was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
HX 1108389-1issued2029-06-20

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