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ASP Global Manufacturing GmbH: FDA-registered device maker in Schaffhausen, Switzerland, 17 510(k) clearances

ASP Global Manufacturing GmbH is registered with the FDA (registration 3015392401) in Schaffhausen, Switzerland. It lists 7 device types. The FDA files 17 510(k) clearances under its listings, the newest dated December 12, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch ASP Global Manufacturing GmbH
FDA registration number
3015392401
Address
Im Majorenacker 10, Schaffhausen, Switzerland, 8207
Owner or operator
Advanced Sterilization Products (9068155)
Roles
Exporter to the US, Manufacturer
First device listed
July 8, 1999
Registered through
2026
Brand names listed
BIOTRACE Instant Read BI (73110), BIOTRACE Instant Read Reader (73430), BIOTRACE Instant Read Steam PCD (73140), BIOTRACE VERISURE and SEALSURE Indicators and Readers, STERRAD 100NX Sterilizer and Cassette (10104, 10104-002, 10144), STERRAD 100NX System DUO Cycle Upgrade Kit (10144, 10104, 10104-002,003,004), STERRAD 100NX System EXPRESS Cycle (10144,10104,10104-002), STERRAD 100NX w ALLClear Technology (10144, 10104ACSW, 10104-005,-006,-007,-008) and more

Devices it lists

DeviceProduct codeClassRoleSource
A Chemical Vapor Sterilization Multivariable Chemical IndicatorQKM2Exporter to the USaccessdata.fda.gov
Biological Sterilization Indicator With Indirect Growth DetectionQVB2Exporter to the USaccessdata.fda.gov
Indicator, Biological Sterilization ProcessFRC2Exporter to the USaccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Exporter to the USaccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Exporter to the USaccessdata.fda.gov
Sterilizer, ChemicalMLR2Manufactureraccessdata.fda.gov
Sterilizer, Ethylene-Oxide GasFLF2Manufactureraccessdata.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 12, 2024K242453Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)FRCSubstantially EquivalentTerragene S.A.accessdata.fda.gov
July 12, 2024DEN220042Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)QVBUnknownTerragene S.A.accessdata.fda.gov
April 5, 2024K232103Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)QKMSubstantially EquivalentTerragene S.A.accessdata.fda.gov
February 28, 2023K221641Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)FRCSubstantially EquivalentTerragene S.A.accessdata.fda.gov
June 30, 2020K200272Terragene ChemdyeJOJSubstantially EquivalentTerragene S.A.accessdata.fda.gov
September 13, 2019K191021Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene ChemdyeFRCSubstantially EquivalentTerragene S.A.accessdata.fda.gov
November 2, 2017K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorFRCSubstantially EquivalentTerragene S.A.accessdata.fda.gov
July 31, 2017K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical IndicatorKCTSubstantially EquivalentAdvanced Sterilization Productsaccessdata.fda.gov
September 27, 2016K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyMLRSubstantially EquivalentAdvanced Sterilization Productsaccessdata.fda.gov
September 26, 2016K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyMLRSubstantially EquivalentAdvanced Sterilization Productsaccessdata.fda.gov
April 3, 2015K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerMLRSubstantially EquivalentAdvanced Sterilization Productsaccessdata.fda.gov
September 13, 2012K111377STERRAD(R) 100NX STERILIZER DUO CYCLEMLRSubstantially EquivalentAdvanced Sterilization Productsaccessdata.fda.gov
March 4, 2011K092622STERRAD 100NX STERILIZER EXPRESS CYCLEMLRSubstantially EquivalentAdvanced Sterilization Productsaccessdata.fda.gov
November 29, 2007K071385STERRAD 100NX STERILIZERMLRSubstantially EquivalentAdvanced Sterilization Productsaccessdata.fda.gov
April 22, 2005K042116STERRAD NX STERILIZERMLRSubstantially EquivalentAdvanced Sterilization Productsaccessdata.fda.gov
April 3, 2003K023290STERRAD 50 & STERRAD 100S STERILIZERSFLFSubstantially EquivalentAdvanced Sterilization Productsaccessdata.fda.gov
June 15, 2000K991999STERRAD 100S STERILIZERMLRSubstantially EquivalentAdvanced Sterilization Productsaccessdata.fda.gov

Compare with other makers

Updated December 12, 2024. 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.