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Ortho Hygiene kit

by ZhenJiang Across Dental Technology Co., Ltd China EUDAMED

Ref Universal-Big BoxModel Universal ,Customized EMDN Q010499

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697837288OHK01TZ Basic UDI-DIDate17 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Ortho Hygiene kit
Model / Reference
Universal, Customized, Universal-Big Box
Primary DI / UDI-DI
06978372880398
Basic UDI-DI
697837288OHK01TZ
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000046637
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from ZhenJiang Across Dental Technology Co., Ltd

See all devices from ZhenJiang Across Dental Technology Co., Ltd →

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 ee626c84-ff12-4db2-9d1b-5cec5b1cb396 61 fields · synced 22 Oct 2026