Data / Medical devices / Italy / Adria.med. SRL

Adria.med. SRL: FDA-registered device maker in Tocco Da Casauria Pescara, Italy, 1 510(k) clearance

Name: Adria.med. SRL FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Adria.med. SRL is registered with the FDA (registration 3013561817) in Tocco Da Casauria Pescara, Italy. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 21, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013561817
Address: Zona Industriale Via Ignazio Silone 1, Tocco Da Casauria Pescara, Italy, 65028
Owner or operator: Adria.Med. SRL (10054479)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: March 24, 2017
Registered through: 2026
Brand names listed: APOTECA DRUG COMPOUNDING DOSING DEVICE, APOTECA I.V. TRANSFER SET, B dispensing line, S Dispensing Line

Devices it lists

Device	Product code	Class	Role	Source
Set, I.V. Fluid Transfer	LHI	2	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
System/Device, Pharmacy Compounding	NEP	2	Contract manufacturer, Contract sterilizer	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
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

Updated March 21, 2014. 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.