Skip to content

Dosing Device

by AEA srl

Part of a family of 10 devices: see the family page

Ref ASN-50-B

Dosing Device (ASN-50-B) is a device classified as Class IIa in the EU and Class II in the US made by Aea SRL, registered in EUDAMED on 14 Nov 2023 (Basic UDI-DI 506030405ASN9K) with CE/MDR certificate MDR 00004-A valid until 9 Aug 2027, cleared under FDA 510(k) K132011 on 21 Mar 2014 and listed in FDA GUDID since 13 Jul 2016 (UDI-DI 05060304050045), expiring (EUDAMED), active (FDA 510(k)) as of 24 Oct 2026.

Expiring Expiring in European Union. Active in United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

9 Aug 2027

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier KIWA CERMET ITALIA S.P.A.

510(k) K132011

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 00004-A Date12 Oct 2026IssuedStatusExpiring expires 9 Aug 2027
United StatesGUDID listing GUDID Number05060304050045 UDI-DI Date13 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK132011 Date21 Mar 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506030405ASN9K registered 14 Nov 2023 Active· +1 more in the status table
  • FDA 510(k) K132011 decided 21 Mar 2014 Active
  • FDA GUDID UDI-DI 05060304050045 listed 13 Jul 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00004-A Expiring Expires in 268 days

    Quality management system EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    12 Oct 2026
    Expires
    9 Aug 2027

Timeline

5 dated events

  1. Cleared FDA 510(k) K132011
  2. Listed FDA GUDID 05060304050045
  3. Registered EUDAMED 506030405ASN9K
  4. Certificate issued EUDAMED MDR 00004-A
  5. Certificate expires EUDAMED MDR 00004-A

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Apoteca
Generic name
Hazardous fluid syringe
Device name
Dosing Device
Model / reference
ASN-50-B EUDAMED
ASN-50 GUDID
Primary DI / UDI-DI
05060304050045
Basic UDI-DI
506030405ASN9K
510(k) Number
FDA product code
FMF
EMDN code
A020102020101 Infusion and irrigation syringes, luer lock cone, 3-piece with needle, single-use
GMDN term
Hazardous fluid syringe
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5860
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
ASN-50-B
GUDID
ASN-50
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
IT-MF-000027519

Similar devices in this category

Other devices filed under INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE, SINGLE-USE.

Other devices from Aea SRL

See all devices from Aea SRL →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)