Data / Medical devices / Italy / Aea SRL
Aea SRL: FDA-registered device maker in Angeli di Rosora Ancona, Italy, 3 510(k) clearances
Aea SRL is registered with the FDA (registration 3006571738) in Angeli di Rosora Ancona, Italy. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 27, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006571738
- Address
- Via Fiume 16, Angeli di Rosora Ancona, Italy, 60030
- Owner or operator
- AEA srl (10035140)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 8, 2011
- Registered through
- 2026
- Brand names listed
- APOTECA Drug Compounding Dosing Device, APOTECA I.V. Transfer Set, APOTECAchemo, APOTECAunit, APOTECAped, APOTECAsyringe, TE Syringe Hive, APOTECAbag, B Dispensing Line, S Dispensing Line
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System/Device, Pharmacy Compounding | NEP | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 27, 2021 | K203674 | B Dispensing Line | LHI | Substantially Equivalent | Aea Srl | accessdata.fda.gov |
| December 17, 2020 | K192770 | S dispensing line | FMF | Substantially Equivalent | Aea Srl | accessdata.fda.gov |
| March 21, 2014 | K132011 | APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET | FMF | Substantially Equivalent | Aea Srl | accessdata.fda.gov |
Compare with other makers
- All makers of System/Device, Pharmacy Compounding
- All makers of Set, I.V. Fluid Transfer
- All makers of Syringe, Piston
Updated September 27, 2021. 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.