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Automatic Blood Grouping and Antibody Analyzer

by Yantai Libbot Biotech Co., Ltd.

Ref TARSEE9000GModel TARSEE9000G,TARSEE6000G,TARSEE3000G,OMNI9000G,OMNI6000G,OMNI3000G,KARL90G,KARL60G,KARL30G, etc

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697878924ABGAA0018S Basic UDI-DI 06978789240006UDI-DIDate16 Jun 2025RegisteredStatusActive

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  • Withdrawn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
Automatic Blood Grouping and Antibody Analyzer
Model / Reference
TARSEE9000G, TARSEE6000G, TARSEE3000G, OMNI9000G, OMNI6000G, OMNI3000G, KARL90G, KARL60G, KARL30G, etc
Primary DI / UDI-DI
06978789240006
Basic UDI-DI
697878924ABGAA0018S
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048177
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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