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MAGICL D-Dimer (CLIA)

by Getein Biotech, Inc. 2 variants

Ref CLIA3055A

MAGICL D-Dimer (CLIA) (CLIA3055A) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category D-dimer) made by Getein Biotech, Inc, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-06954414733594), active as of 7 Nov 2026.

Active European Union

CE IVDD

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06954414733594 Basic UDI-DI Date26 Oct 2026RegisteredStatusActive

Official records

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  • Withdrawn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
CLIA3055A
Primary DI / UDI-DI
06954414733594, 06954414729009, 06954414733723
Basic UDI-DI
B-06954414733594, B-06954414729009, B-06954414733723
EMDN code
W0103020503 D-dimer
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000017986
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Similar devices in this category

Other devices filed under D-DIMER.

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)