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ultrasound probe cover

by Dongyang Songpu Latex (Jinzhou) Co., Ltd. 2 variants

Ref 6453

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDR Number693443972549KS Basic UDI-DI 06934439764537UDI-DIDate27 Apr 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
ultrasound probe cover
Model / Reference
6453
Primary DI / UDI-DI
06934439764537
Basic UDI-DI
693443972549KS
EMDN Code
T030102 Cover sheaths, instruments and equipments
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000036502
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Dongyang Songpu Latex (Jinzhou) Co., Ltd.

See all devices from Dongyang Songpu Latex (Jinzhou) Co., Ltd. →

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • New Device: No