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Securegard 1.0

by SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag 22 variants

Securegard 1.0 (5158E) is a Class II device made by SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag, cleared under FDA 510(k) K993609 on 17 Mar 2000, registered in EUDAMED and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05999039508579), 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
United StatesGUDID listing GUDID Number05999039508579 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK993609 Date17 Mar 2000DecidedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K993609 decided 17 Mar 2000 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 05999039508579 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K993609
  2. Listed FDA GUDID 05999039508579

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  • Withdrawn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
1.0, 5158E
Primary DI / UDI-DI
05999039508579
510(k) Number
FDA product code
MEG
GMDN term
Metered-delivery hypodermic syringe/needle
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metered-delivery hypodermic syringe/needle

Cleared under the same submission (K993609)

and 8 more cleared under K993609

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
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)