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Disposable Sterile Prefilled Saline Flush

by Jiangsu Zhida Pharmaceutical Co., Ltd EUDAMED

Active European Union

Ref ZDA-PFS0218

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697783593ZDA-PFS0218GY Basic UDI-DIDate9 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.25/6025 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    18 Dec 2025
    Expires
    17 Dec 2030

Specification

EUDAMED

Model / Reference
ZDA-PFS0218
Primary DI / UDI-DI
06977835930038
Basic UDI-DI
697783593ZDA-PFS0218GY
Direct Marketing DI
06977835930038
EMDN Code
A02010701 Prefilled syringes with sterile physiological solution
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000044873
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Jiangsu Zhida Pharmaceutical 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