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Disposable transfer pipette(Capillary pipette/Glass capillary tube/Fixed volume pipette/Capillary blood collector)

by Jiangsu Kehua Medical Instrument Technology Co., Ltd.

Ref EDTAK2Model 2-200ul EDTAK2,EDTAK3,Heparin sodium, Heparin lithium, Sodium Citrate, Sodium fluoride/potassium oxalate, Sodium fluoride/Heparin lithium, Sodium fluoride/EDTAK2

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 Number697095264DTP001LP Basic UDI-DI 06970952649500UDI-DIDate15 Jun 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  • Withdrawn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
Disposable transfer pipette(Capillary pipette/Glass capillary tube/Fixed volume pipette/Capillary blood collector)
Model / Reference
2-200ul EDTAK2, EDTAK3, Heparin sodium, Heparin lithium, Sodium Citrate, Sodium fluoride/potassium oxalate, Sodium fluoride/Heparin lithium, Sodium fluoride/EDTAK2, EDTAK2
Primary DI / UDI-DI
06970952649500
Basic UDI-DI
697095264DTP001LP
EMDN Code
W0503020199 Pipettes - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000028654
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Jiangsu Kehua Medical Instrument Technology Co., Ltd.

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Properties

  • Professional Testing

Other properties (10)

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