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Securegard 1.0

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

Ref 5318RModel 1 ml 25Gx1"

Securegard 1.0 (5318R) is a device classified as Class IIa in the EU and Class II in the US made by SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag, registered in EUDAMED on 29 May 2026 (Basic UDI-DI B-05999039512095), cleared under FDA 510(k) K993609 on 17 Mar 2000 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05999039512095), active as of 22 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K993609

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05999039512095 Basic UDI-DI 05999039512095UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05999039512095 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK993609 Date17 Mar 2000DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05999039512095 registered 29 May 2026 Active
  • FDA 510(k) K993609 decided 17 Mar 2000 Active
  • FDA GUDID UDI-DI 05999039512095 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K993609
  2. Listed FDA GUDID 05999039512095
  3. Registered EUDAMED B-05999039512095

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Securegard
Generic name
Metered-delivery hypodermic syringe/needle
Model / Ref / Catalog
1 ml 25Gx1", 5318R, 1.0
Primary DI / UDI-DI
05999039512095
Basic UDI-DI
B-05999039512095
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 registration type
Legacy device (under a directive)
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1 ml 25Gx1"
5318R
GUDID
1.0
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.

Related devices

Category: Metered-delivery hypodermic syringe/needle

Cleared under the same submission (K993609)

and 8 more cleared under K993609

Similar devices in this category

Other devices filed under HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS.

Other devices from SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag

  • Securegard 1.0

    Class II

  • Securegard 1.0

    Class II

  • Securegard 1.0

    Class II

  • Securegard 1.0

    Class II

See all devices from SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag →

Properties

  • Supplied sterile
  • Single use
  • Measuring function
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)