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Mouth Tape

by Dongguan Xinhongke Adhesive Products Co., Ltd. China EUDAMED

Ref XH507Model XHK601 XHK602 XHK605 XHK608 XHK609 XHK6010 XH501 XH502 XH505 XH507 XH509 XH5010 801 802 8015 8010 8080

EMDN Q03010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698010006MOTLJ Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Mouth Tape
Model / Reference
XHK601 XHK602 XHK605 XHK608 XHK609 XHK6010 XH501 XH502 XH505 XH507 XH509 XH5010 801 802 8015 8010 8080, XH507
Primary DI / UDI-DI
06980100060682
Basic UDI-DI
698010006MOTLJ
EMDN Code
Q03010299 Antisnoring and obstructive sleep apnoea devices - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000054518
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED cb7f59a9-3b29-4140-ade8-e8e11ef32744 61 fields · synced 22 Oct 2026