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APOTECAsyringe

by Aea SRL

APOTECAsyringe is a Class II device made by Aea SRL, listed in FDA GUDID since 1 Mar 2021 (UDI-DI 05060304050250), registry data as of 1 Jun 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 1 Jun 2026.

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060304050250 UDI-DI Date1 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Pharmaceutical fluid-dispensing system
Model / reference
APOTECAsyringe
Primary DI / UDI-DI
05060304050250
FDA product code
NEP
GMDN term
Pharmaceutical fluid-dispensing system
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pharmaceutical fluid-dispensing system

Other devices from Aea SRL

See all devices from Aea SRL →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)