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Safety Intravenous Needles for single use

by Shandong Caremed Medical Products Co., Ltd. 10 variants

Ref 22GModel 18G,19G,20G,21G,22G,23G,24G,25G,26G,27G,28G

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) K221078↗

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 Number697652354ASZ001MS Basic UDI-DI 16976523541539UDI-DIDate21 Aug 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK221078 Date21 Nov 2022IssuedStatusActive

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  • Withdrawn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 Intravenous Needles for single use
Model / Reference
18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G
Primary DI / UDI-DI
16976523541539
Basic UDI-DI
697652354ASZ001MS
EMDN Code
A01010201 Butterfly needles, with safety systems
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000033413
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shandong Caremed Medical Products Co., Ltd

See all devices from Shandong Caremed Medical Products 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