Apoteca ADY1200CF

Apoteca ADY1200CF is a Class II device made by Aea SRL, cleared under FDA 510(k) K132011 on 21 Mar 2014 and listed in FDA GUDID since 13 Jul 2016 (UDI-DI 05060304050137), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05060304050137 UDI-DI	Date13 Jul 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated	NumberK132011	Date21 Mar 2014Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05060304050137
FDA 510(k) database 510(k) number K132011

Across registries

2 registries list this device

FDA 510(k) K132011 decided 21 Mar 2014 Active
FDA GUDID UDI-DI 05060304050137 listed 13 Jul 2016 Listed

Timeline

2 dated events

21 Mar 2014 Cleared FDA 510(k) K132011
13 Jul 2016 Listed FDA GUDID 05060304050137

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Apoteca
Generic name: Fluid transfer set, general-purpose
Model / reference: ADY1200CF

Primary DI / UDI-DI: 05060304050137
510(k) Number: K132011
FDA product code: LHI
GMDN term: Fluid transfer set, general-purpose

Device class: Class II
Regulation number: 880.5440
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Fluid transfer set, general-purpose.

Other devices from Aea SRL

See all devices from Aea SRL →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (9, all answered No)