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HPV Screen Sampling Kits

by Jiangsu HanHeng Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref HPV-83-5Model HPV-83-2, HPV-83-3, HPV-83-5, HPV-83-8, HPV-83-10, HPV-83-12

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697369781858SV Basic UDI-DIDate23 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
HPV Screen Sampling Kits
Model / Reference
HPV-83-2, HPV-83-3, HPV-83-5, HPV-83-8, HPV-83-10, HPV-83-12
Primary DI / UDI-DI
06973697818606
Basic UDI-DI
697369781858SV
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023013
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jiangsu HanHeng Medical Technology Co., Ltd

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

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No