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Data / Medical devices / Germany / Gebr. Schwarz GmbH

Gebr. Schwarz GmbH: FDA-registered device maker in Rottweil Baden-Wurttemberg, Germany, 1 510(k) clearance

Gebr. Schwarz GmbH is registered with the FDA (registration 3012055599) in Rottweil Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 1994. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3012055599
Address
Zepfenhaner Strabe 35, Rottweil Baden-Wurttemberg, Germany, 78628
Owner or operator
Gebr. Schwarz GmbH (10051999)
Roles
Contract manufacturer, Repackager or relabeler
First device listed
May 31, 2016
Registered through
2026
Brand names listed
Sterilization locks

Devices it lists

DeviceProduct codeClassRoleSource
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Contract manufacturer, Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 20, 1994K944864PRIMED RIGID CONTAINER SYSTEMKCTSubstantially EquivalentPrimed, Inc.accessdata.fda.gov

Compare with other makers

Updated December 20, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.