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Securegard 1.0

by SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag 2 variants

Ref 5348EModel 3 ml 23Gx1"

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD EUDAMED NumberB-05999039508425 Basic UDI-DI 05999039508425UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05999039508425 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Securegard
Generic Name
Metered-delivery hypodermic syringe/needle
Model / Ref / Catalog
3 ml 23Gx1", 5348E, 1.0
Primary DI / UDI-DI
05999039508425
Basic UDI-DI
B-05999039508425
510(k) Number
FDA Product Code
MEG
EMDN Code
A0101010101 Hypodermic syringe needles, with safety systems
GMDN Term
Metered-delivery hypodermic syringe/needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5860
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
3 ml 23Gx1"
5348E
GUDID
1.0
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K993609)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Measuring Function
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No