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Magicl FT3 (Clia) CLIA3008A

by Getein Biotech, Inc 2 variants

Ref CLIA3008A

Magicl FT3 (Clia) CLIA3008A is a device classified as IVD General made by Getein Biotech, Inc, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-06954414735635) and listed in FDA GUDID since 10 Jul 2026 (UDI-DI 06954414735635), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-06954414735635 Basic UDI-DI Date26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06954414735635 UDI-DI Date10 Jul 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-06954414735635 registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 06954414735635 listed 10 Jul 2026 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 06954414735635
  2. Registered EUDAMED B-06954414735635

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Magicl FT3 (Clia)
Generic name
Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
CLIA3008A
Primary DI / UDI-DI
06954414735635, 06954414728811, 06954414728125
Basic UDI-DI
B-06954414735635, B-06954414728811, B-06954414728125
EMDN code
W01020401 Free triiodothyronine
GMDN term
Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under FREE TRIIODOTHYRONINE.

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Properties

  • Single use
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)