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Disposable Cervical Sampler

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

Ref 831603Model 8311;8312;8313;8314;8315;831601;831602;831603;8317

EMDN U089002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697369781233RF Basic UDI-DIDate21 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 Sampler
Model / Reference
8311, 8312, 8313, 8314, 8315, 831601, 831602, 831603, 8317
Primary DI / UDI-DI
06973697812406
Basic UDI-DI
697369781233RF
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

Other devices from Jiangsu HanHeng Medical Technology Co., Ltd

See all devices from Jiangsu HanHeng Medical Technology Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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 dc23320e-72a8-4d99-8341-9acae4878a10 61 fields · synced 24 Oct 2026