Data / Medical devices / Italy / Elcam Medical Italy SPA
Elcam Medical Italy SPA: FDA-registered device maker in CARPI Modena, Italy, 2 510(k) clearances
Elcam Medical Italy SPA is registered with the FDA (registration 3004960482) in CARPI Modena, Italy. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 24, 1986. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004960482
- Address
- 15, Via Emilia-Romagna, CARPI Modena, Italy, 41012
- Owner or operator
- ELCAM MEDICAL ITALY SPA (9094403)
- Roles
- Manufacturer
- First device listed
- November 8, 2006
- Registered through
- 2026
- Brand names listed
- 07103300/S - RECIRCULATION FLL CONNECTOR WITH VENTED CAP, 175IBLSSC - CATHETHER INJECTION PORT, 7001-3902W - RECIRCULATION CONNECTOR, 7001-3915 - NON INJECTABLE CATHETER CAP, 7001-3926 - INJECTION SITE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Catheter | GCE | 1 | Manufacturer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | 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 |
|---|---|---|---|---|---|---|
| January 24, 1986 | K855039 | MEDIFLEX INJECTION CAP | GCE | Substantially Equivalent | Mediflex Intl. | accessdata.fda.gov |
| July 29, 1985 | K852605 | BLOOD TUBING SET | FJK | Substantially Equivalent | Medflex International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- All makers of Adaptor, Catheter
Updated January 24, 1986. 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.