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Single Use Sterile Pulse Flushing System for Wound Care

by SAC(Xiamen) Medical Technology Co., Ltd.

Ref 6305015000Model SAC-WPWS-1000

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06958655002365 Basic UDI-DI 06958655002365UDI-DIDate25 May 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
SAC-WPWS-1000, 6305015000
Primary DI / UDI-DI
06958655002365
Basic UDI-DI
B-06958655002365
EMDN Code
Z12019003 Wound treatment equipment
Device Class
Class IIa
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000023943
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from SAC(Xiamen) Medical Technology Co., Ltd.

Properties

  • Sterile

Other properties (10)

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