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Data / Medical devices / Switzerland / Comepsa Ltd

Comepsa Ltd: FDA-registered device maker in Chiasso Ticino, Switzerland, 19 510(k) clearances

Comepsa Ltd is registered with the FDA (registration 3009328501) in Chiasso Ticino, Switzerland. It lists 12 device types. The FDA files 19 510(k) clearances under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Comepsa Ltd
FDA registration number
3009328501
Address
Via Livio 24, Chiasso Ticino, Switzerland, 6830
Owner or operator
COMEPSA LTD (10080291)
Roles
Exporter to the US
First device listed
January 25, 2021
Registered through
2026
Brand names listed
GREINER-NEEDLE,HYPODERMIC, SAFETY INFUSION SET, SET, ADMINISTRATION, INTRAVASCULAR

Devices it lists

DeviceProduct codeClassRoleSource
Anoscope And AccessoriesFER2Exporter to the USaccessdata.fda.gov
ArthroscopeHRX2Exporter to the USaccessdata.fda.gov
Cannula, Manipulator/Injector, UterineLKF2Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Filter, Infusion LineFPB2Exporter to the USaccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Exporter to the USaccessdata.fda.gov
Lung Sound MonitorOCR2Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Set, Administration, IntravascularFPA2Exporter to the USaccessdata.fda.gov
Speculum, Vaginal, NonmetalHIB2Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
System, Irrigation, UrologicalLJH2Exporter to the USaccessdata.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
February 28, 2025K242339Intravascular Extension Sets and AccessoriesFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
May 28, 2019K180739Clearlink System Solution SetFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
December 28, 2015K153158Solution Administration Sets with 0.2 Micron FilterFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
January 8, 2013K123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SETFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
October 18, 2011K112893CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETSFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
March 25, 2011K103551INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,FPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
April 24, 2008K080235SAFETY INFUSION SETFMISubstantially EquivalentGreiner Bio-One Vacuette North Americaaccessdata.fda.gov
March 9, 2007K062909REPEATER PUMP II TUBE SETSFPASubstantially EquivalentBaxa Corp.accessdata.fda.gov
May 6, 2003K030580SURETEMP PLUSFLLSubstantially EquivalentWelch Allyn, Inc.accessdata.fda.gov
March 9, 1998K980123CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SETGCJSubstantially EquivalentLouisville Laboratories, Inc.accessdata.fda.gov
June 21, 1996K961225CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
May 14, 1996K960787TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSLJHSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
October 7, 1995K951254SAFETYGLIDE NEEDLEFMISubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
June 24, 1994K932115ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMILKFSubstantially EquivalentBlairden Precision Instruments, Inc.accessdata.fda.gov
June 18, 1993K925126INTERLINK(TM) INJECTION SITEFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
April 20, 1993K921899INTERLINK SYSTEM - T-CONNECTOR EXTENSION SETFPASubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
October 9, 1987K872743BAXA TUBING SETS (FOR PHARMACY PUMP)FMFSubstantially EquivalentBaxa Corp., Sub. of Cook Group, Inc.accessdata.fda.gov
June 13, 1986K861017GALENICA'S DISPOSABLE ANOSCOPESFERSubstantially EquivalentGalenica Enterprises, Inc.accessdata.fda.gov
July 31, 1984K841909VAGINAL SPECULUM - DISPOSABLEHIBSubstantially EquivalentGalenica Enterprises, Inc.accessdata.fda.gov

Compare with other makers

Updated February 28, 2025. 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.