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Pipette

by BioTeke Corporation（Wuxi）Co., Ltd 11 variants

Ref PT200Model PT10, PT50, PT100, PT200, PT1000, PT5000, PTE10, PTE50, PTE100, PTE200, PTE300

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697454156011KW Basic UDI-DI 06974541565127UDI-DIDate15 May 2026RegisteredStatusActive

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  • Withdrawn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
Pipette
Model / Reference
PT10, PT50, PT100, PT200, PT1000, PT5000, PTE10, PTE50, PTE100, PTE200, PTE300
Primary DI / UDI-DI
06974541565127
Basic UDI-DI
697454156011KW
EMDN Code
W0503020199 Pipettes - other
Device Class
Class A
EU market of registration
Bulgaria

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

  • Surgical Instrument

Other properties (10)

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