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Intra-oral Sensor Sheaths

by Suzhou Pac-Dent Technology Co., Ltd. China EUDAMED

Ref 1.013.3253 EMDN Q010599

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697316311DBS00001CR Basic UDI-DIDate28 Jul 2026RegisteredStatusActive

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  • Withdrawn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 23 Oct 2026

Device Name
Disposable barrier sleeves
Model / Reference
1.013.3253
Primary DI / UDI-DI
06973163110296
Basic UDI-DI
697316311DBS00001CR
EMDN Code
Q010599 Dental instruments, single-use - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000021642
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

Other devices from Suzhou Pac-Dent Technology Co., Ltd.

See all devices from Suzhou Pac-Dent 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 01ea150c-6fd5-4546-9f95-1cee68b68265 61 fields · synced 23 Oct 2026