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Hematology Analysis Lytic Agent

by Zhejiang xinke Medical Technology Co., Ltd. 171 variants

Ref 06970293020778

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697029302lytic0013N Basic UDI-DI 06970293020778UDI-DIDate27 Jun 2024RegisteredStatusActive

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  • Withdrawn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
Hematology Analysis Lytic Agent
Model / Reference
06970293020778
Primary DI / UDI-DI
06970293020778
Basic UDI-DI
697029302lytic0013N
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000032274
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Zhejiang xinke Medical Technology Co., Ltd.

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Properties

Other properties (11)

  • 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
  • Surgical Instrument: No
  • New Device: No