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Safety venous blood collection needle for single use

by Chengdu Puth Medical Technology Co., Ltd. 14 variants

Ref 694799002662Model Flash-back with Window type (AQKJ)

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 26 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212019↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69479900AQCXZ/AQKJLV Basic UDI-DI 06947990026624UDI-DIDate14 Sep 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK212019 Date4 Nov 2021IssuedStatusActive

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 26 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  • Withdrawn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)

Model / Reference
Flash-back with Window type (AQKJ), 694799002662
Primary DI / UDI-DI
06947990026624
Basic UDI-DI
69479900AQCXZ/AQKJLV
Unit of Use DI
16947990026621
EMDN Code
A01010501 Needles for collection under vacuum, with safety systems
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000005947
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Chengdu Puth Medical Technology Co., Ltd.

See all devices from Chengdu Puth Medical Technology 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