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Irrigation needle

by Guangxi Ehall Medical Technology Co., Ltd 5 variants

Ref Half cutModel single vent

Active European Union

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697468494IN01RN Basic UDI-DI 06974684940119UDI-DIDate13 Nov 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Irrigation needle
Model / Reference
single vent, Half cut
Primary DI / UDI-DI
06974684940119
Basic UDI-DI
697468494IN01RN
EMDN Code
Q010599 Dental instruments, single-use - other
Device Class
Class I
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000044977
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Guangxi Ehall Medical Technology Co., Ltd

See all devices from Guangxi Ehall Medical Technology Co., Ltd →

Properties

Other properties (13)

  • Sterile: No
  • 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