Skip to content

Dental Floss

by Shandong Hengfeng Kerui Medical Equipment Co., Ltd 2 variants

Ref HF-600DModel HF-400D、HF-600D、HF-800D、HF-1500D、HF-PE、HF-PTFE

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 Number69363400DF001D9 Basic UDI-DI 06936340035539UDI-DIDate27 Nov 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
HF-400D、HF-600D、HF-800D、HF-1500D、HF-PE、HF-PTFE, HF-600D
Primary DI / UDI-DI
06936340035539
Basic UDI-DI
69363400DF001D9
EMDN Code
Q019003 Dental floss and other devices for oral hygiene (for professional use)
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000042567
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shandong Hengfeng Kerui Medical Equipment Co., Ltd

See all devices from Shandong Hengfeng Kerui Medical Equipment 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