EU → North America Device Access

terraplasma medical GmbH

DE-MF-000011250 · Germany · Garching b. München

terraplasma medical GmbH is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13

Among these devices, 2 are declared sterile, 11 active.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include PC100004, PC100005, PC100006, PC100011, VB319002, VB319003.

European nomenclature codes declared: V9099, Z12019003.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
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 GTIN13
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. terraplasma medical GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
HZ 1380540-1issued2029-11-12

Other manufacturers in Germany

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