Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006571738

FEI Number

3006571738

Entity Name

AEA SRL

City/State/Country

Angeli di Rosora Ancona, IT

Establishment Address

Via Fiume 16, Angeli di Rosora Ancona 60030, IT

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

AEA srl (Owner Number: 10035140)

Owner / Operator Contact Address

Via Fiume 16, Angeli di Rosora, IT-AN 60030, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192770

PMA Number

N/A

All Registered Proprietary Names

APOTECA I.V. Transfer Set APOTECA Drug Compounding Dosing Device APOTECAchemo, APOTECAunit, APOTECAped, APOTECAsyringe, TE Syringe Hive, APOTECAbag S Dispensing Line

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2014-04-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-04-01
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2011-02-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-02-26
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2021-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

IGNAZIO DROGHINI Business: Loccioni Usa Inc. Email: i.droghini@loccioni.com Phone: (301) 3014777

Related Public Records

Same Entity

AEA srl

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

Similar Registrations

Registration Number	Establishment Name	Location
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006571738. Last updated year: 2026. Please use registration number 3006571738 when referencing this establishment in official correspondence.