Skip to content

EasyPoint® 85231

by Retractable Technologies, Inc.

Ref 85231

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00613703852304 UDI-DI Date18 Apr 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0613703EasyPoint2B Basic UDI-DI 00613703852304UDI-DIDate19 Jan 2023RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK133635 Date17 Jun 2014IssuedStatusActive

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

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.

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  • Withdrawn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
85231
Primary DI / UDI-DI
00613703852304
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

Related devices

Category: Hypodermic needle, single-use

Cleared under the same submission (K133635)

Show all (12)

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)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No