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
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Enteral Specific Transition Connectors | PIO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Contract manufacturer, Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 9, 2019 | K190327 | ENConnect 40 mm Screw Cap to ENPlus Adapter | PIF | Substantially Equivalent | Cedic S.R.L. | accessdata.fda.gov |
| May 4, 2017 | K162254 | Cedic Enteral ENFit Transition Connectors | PIO | Substantially Equivalent | Cedic S.R.L. | accessdata.fda.gov |
| April 2, 2015 | K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port | PIO | Substantially Equivalent | Cedic S.R.L. | accessdata.fda.gov |
| October 17, 2014 | K140581 | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT | PIO | Substantially Equivalent | Cedic S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Enteral Specific Transition Connectors
- All makers of Dispenser, Liquid Medication
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.