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Bexen MEDICAL Safety Vacuum Blood Collection Needles 21G×19mm

by Yangzhou Medline Industry Co., Ltd. 2 variants

Ref PSP2119Model butterfly type, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G With Holder

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) K213146↗

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 Number69418452MDLSVBCSBTMC Basic UDI-DI 06941845224388UDI-DIDate16 Dec 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK213146 Date27 Oct 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  • Withdrawn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
Safety Vacuum Blood Collection Needles
Model / Reference
butterfly type, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G With Holder, PSP2119
Primary DI / UDI-DI
06941845224388
Basic UDI-DI
69418452MDLSVBCSBTMC
EMDN Code
A01010501 Needles for collection under vacuum, with safety systems
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000026644
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Yangzhou Medline Industry Co., Ltd.

See all devices from Yangzhou Medline Industry Co., Ltd. →

Properties

  • Sterile

Other properties (12)

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