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Ɣ- Glutamyl transferase (GGT) (4+1)

by Kalians Corporation 3 variants

Ref D-621 001

Active European Union

CE IVDD

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/IVDD NumberB-62230182708368 Basic UDI-DI 62230182708368UDI-DIDate30 Mar 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
D-621 001
Primary DI / UDI-DI
62230182708368
Basic UDI-DI
B-62230182708368
EMDN Code
W01010116 Gamma glutamyltransferase
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
EG-MF-000050142
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Gamma-glutamyltransferase (GGT) IVD, reagent

Other devices from Kalians Corporation

See all devices from Kalians Corporation →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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