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Disposable Cervical Samplers (non-sterile)

by Jiangsu HanHeng Medical Technology Co., Ltd. China EUDAMED

Ref 84031Model 83/84-series

EMDN U089002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697369781638SD Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Disposable Cervical Samplers (non-sterile)
Model / Reference
83/84-series, 84031
Primary DI / UDI-DI
06973697819382
Basic UDI-DI
697369781638SD
EMDN Code
U089002 Devices for gynaecological cytology
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018784
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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 d3d25ffa-9b85-44d5-90da-06c357a561bd 61 fields · synced 24 Oct 2026