Skip to content

Saliva Collection Kit

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

Ref HH-5-B3Model HH-5-B2、HH-5-B3、HH-10-B2、HH-10-B3、HH-10-B4、HH-10-B5、HH-10-B6、HH-10-B8

EMDN W05019002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697369781215RD Basic UDI-DIDate23 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Saliva Collection Kit
Model / Reference
HH-5-B2、HH-5-B3、HH-10-B2、HH-10-B3、HH-10-B4、HH-10-B5、HH-10-B6、HH-10-B8, HH-5-B3
Primary DI / UDI-DI
06973697812161
Basic UDI-DI
697369781215RD
EMDN Code
W05019002 Saliva collection devices
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED c5345c7d-b659-472d-b74b-b7daf6fba4a8 61 fields · synced 22 Oct 2026