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OffiSoins- Insulin pen needle for single use

by Anhui Hongyu Wuzhou Medical Manufacturer CO., Ltd. 2 variants

Ref HWIPN3108, HWIPN3105Model 32G(0.23mm), 31G(0.25mm), 30G(0.30mm), 29G(0.33mm)

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230043↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69586976HWYDZ001ZN Basic UDI-DI Date1 Jul 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK230043 Date20 Sep 2023IssuedStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device Name
Insulin Pen Needles for Single Use
Model / Reference
32G(0.23mm), 31G(0.25mm), 30G(0.30mm), 29G(0.33mm), HWIPN3108, HWIPN3105
Primary DI / UDI-DI
06958697620879, 06958697620510
Basic UDI-DI
69586976HWYDZ001ZN
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000029789
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Anhui Hongyu Wuzhou Medical Manufacturer CO., Ltd.

See all devices from Anhui Hongyu Wuzhou Medical Manufacturer CO., Ltd. →

Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No