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APOTECA S Dispensing Line

by Aea SRL

Ref SDL-01-STD

Expiring European Union. Also listed in GUDID (US).

CE MDR

Valid until

9 Aug 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier KIWA CERMET ITALIA S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 00004-A Date12 Oct 2026IssuedStatusExpiring expires 9 Aug 2027
United StatesGUDID listing GUDID Number05060304050823 UDI-DI Date1 Mar 2021ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00004-A Expiring Expires in 280 days

    Quality management system EU MDR

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
S Dispensing Line EUDAMED
Apoteca GUDID
Generic Name
Fluid transfer set, general-purpose
Model / Ref / Catalog
SDL-01-STD, S Dispensing Line
Primary DI / UDI-DI
05060304050823
Basic UDI-DI
506030405SDLAU
FDA Product Code
LHI, FMF
EMDN Code
A0399 Tubular devices - other
GMDN Term
Fluid transfer set, general-purpose
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5440, 880.5860
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SDL-01-STD
GUDID
S Dispensing Line
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Aea SRL

See all devices from Aea SRL →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No