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VanishPoint® 11031

by Retractable Technologies, Inc.

Part of a family of 45 devices: see the family page

Ref 11031

VanishPoint® 11031 is a device classified as Class IIa in the EU and Class II in the US made by Retractable Technologies, Inc., registered in EUDAMED on 18 Jan 2023 (Basic UDI-DI 0613703VPsyringeF9), cleared under FDA 510(k) K970803 on 29 May 1997 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00613703110305), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K970803

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 Number0613703VPsyringeF9 Basic UDI-DI 00613703110305UDI-DIDate18 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00613703110305 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK970803 Date29 May 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0613703VPsyringeF9 registered 18 Jan 2023 Active
  • FDA 510(k) K970803 decided 29 May 1997 Active
  • FDA GUDID UDI-DI 00613703110305 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K970803
  2. Listed FDA GUDID 00613703110305
  3. Registered EUDAMED 0613703VPsyringeF9

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
VanishPoint Syringe EUDAMED
VanishPoint® GUDID
Generic name
Metered-delivery hypodermic syringe/needle
Model / Ref / Catalog
11031
Primary DI / UDI-DI
00613703110305
Basic UDI-DI
0613703VPsyringeF9
510(k) Number
FDA product code
MEG
EMDN code
A02010205 Infusion and irrigation syringes with safety system, single-use
GMDN term
Metered-delivery hypodermic syringe/needle
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5860
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 (K970803)

and 8 more cleared under K970803

Similar devices in this category

Other devices filed under INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE.

Other devices from Retractable Technologies, Inc.

See all devices from Retractable Technologies, Inc. →

Properties

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