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EasyPoint® 85031

by Retractable Technologies, Inc.

Part of a family of 16 devices: see the family page

Ref 85031

EasyPoint® 85031 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 19 Jan 2023 (Basic UDI-DI 0613703EasyPoint2B), cleared under FDA 510(k) K133635 on 17 Jun 2014 and listed in FDA GUDID since 18 Apr 2023 (UDI-DI 00613703850300), active as of 24 Oct 2026. One FDA recall is linked to it.

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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133635

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00613703850300 UDI-DI Date18 Apr 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0613703EasyPoint2B Basic UDI-DI 00613703850300UDI-DIDate19 Jan 2023RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK133635 Date17 Jun 2014IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0613703EasyPoint2B registered 19 Jan 2023 Active
  • FDA 510(k) K133635 decided 17 Jun 2014 Active
  • FDA GUDID UDI-DI 00613703850300 listed 18 Apr 2023 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1293-2024 FDA Class II initiated 5 Feb 2024

    The needle cannula of a retractable needle may detach from the needle holder in the patient.

Timeline

4 dated events

  1. Cleared FDA 510(k) K133635
  2. Registered EUDAMED 0613703EasyPoint2B
  3. Listed FDA GUDID 00613703850300
  4. Recall initiated FDA recalls Z-1293-2024

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  • Withdrawn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
EasyPoint Needle EUDAMED
EasyPoint® GUDID
Generic name
Hypodermic needle, single-use
Model / Ref / Catalog
85031
Primary DI / UDI-DI
00613703850300
Basic UDI-DI
0613703EasyPoint2B
510(k) Number
FDA product code
FMI
EMDN code
A0101010101 Hypodermic syringe needles, with safety systems
GMDN term
Hypodermic needle, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5570
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: Hypodermic needle, single-use

Cleared under the same submission (K133635)

and 8 more cleared under K133635

Similar devices in this category

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

Other devices from Retractable Technologies, Inc.

See all devices from Retractable Technologies, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)