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CEA Control (CLIA)

by Getein Biotech, Inc.

Ref QC546

CEA Control (CLIA) (QC546) is a device classified as IVD General made by Getein Biotech, Inc, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-06954414753738), 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-06954414753738 Basic UDI-DI Date5 Nov 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  • Withdrawn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
QC546
Primary DI / UDI-DI
06954414753738, 06954414755947, 06954414748284, 06954414754780
Basic UDI-DI
B-06954414753738, B-06954414755947, B-06954414748284, B-06954414754780
EMDN code
W0102152005 Tumour marker controls
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 TUMOUR MARKER CONTROLS.

Other devices from Getein Biotech, Inc

See all devices from Getein Biotech, Inc →

Properties

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