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Data / Medical devices / Italy / Cedic S.R.L.

Cedic S.R.L.: FDA-registered device maker in PESCHIERA BORROMEO MILAN Lombardy, Italy, 4 510(k) clearances

Cedic S.R.L. is registered with the FDA (registration 3003593728) in PESCHIERA BORROMEO MILAN Lombardy, Italy. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 9, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3003593728
Address
Via Liberazione, 63/9, PESCHIERA BORROMEO MILAN Lombardy, Italy, 20068
Owner or operator
CEDIC S.R.L. (9063446)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
December 4, 2014
Registered through
2026
Brand names listed
Bolink D Cap Gravity Feeding Set with ENFit Connector - BK-2260, Bolink Large Cap Gravity Feeding Set with ENFit Connector - BK-2405, Bolink Large cap gravity feeding set with ENFit connector BK-1405, Bolink Small Cap Gravity Feeding Set with Cross Spike & ENFit Connector- BK-2085, Bolink Small cap gravity feeding set with cross spike and ENFit connector BK-1085, ENCONNECT DOUBLE MALE ENFIT - A560, ENCONNECT ENFIT STEPPED BOTTLE ADAPTER - A540, ENConnect 40mm Screw Cap to ENPlus Adapter and more

Devices it lists

DeviceProduct codeClassRoleSource
Dispenser, Liquid MedicationKYX1Manufacturer, Specification developeraccessdata.fda.gov
Enteral Specific Transition ConnectorsPIO2Manufacturer, Specification developeraccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Contract manufacturer, Manufactureraccessdata.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
April 9, 2019K190327ENConnect 40 mm Screw Cap to ENPlus AdapterPIFSubstantially EquivalentCedic S.R.L.accessdata.fda.gov
May 4, 2017K162254Cedic Enteral ENFit Transition ConnectorsPIOSubstantially EquivalentCedic S.R.L.accessdata.fda.gov
April 2, 2015K150010Cedic Oral/Luer Enteral ENFit Transition Connector for Medication PortPIOSubstantially EquivalentCedic S.R.L.accessdata.fda.gov
October 17, 2014K140581CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORTPIOSubstantially EquivalentCedic S.R.L.accessdata.fda.gov

Compare with other makers

Updated April 9, 2019. 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.