Skip to content

Disposable Virus Sampling Swab Kits

by BioTeke Corporation（Wuxi）Co., Ltd China EUDAMED

Ref ST9001-2Model ST7001-0, ST7001-1, ST7001-2, ST8001-0, ST8001-1, ST8001-2, ST9001-0, ST9001-1, ST9001-2 EMDN W05019099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697454156004KZ Basic UDI-DIDate28 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Disposable Virus Sampling Swab Kits
Model / Reference
ST7001-0, ST7001-1, ST7001-2, ST8001-0, ST8001-1, ST8001-2, ST9001-0, ST9001-1, ST9001-2
Primary DI / UDI-DI
06974541564922
Basic UDI-DI
697454156004KZ
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
CN-MF-000007517
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Bioteke Corporation (Wuxi) Co., Ltd.

See all devices from Bioteke Corporation (Wuxi) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED a7f5d278-c331-46d1-a0fa-7f86e9446209 61 fields · synced 25 Oct 2026