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Disposable Virus Sampling Swab Kits

by BioTeke Corporation（Wuxi）Co., Ltd 15 variants

Ref ZK1500-4Model ZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-5

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697454156008L9 Basic UDI-DI 06974541564816UDI-DIDate6 Jul 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Disposable Virus Sampling Swab Kits
Model / Reference
ZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-5
Primary DI / UDI-DI
06974541564816
Basic UDI-DI
697454156008L9
EMDN Code
W0105900103 Supplemental na reagents
Device Class
Class A
EU 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.

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Properties

  • 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