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Thermo Scientific X2T IVD-MD

by Thermo Electron LED GmbH EUDAMEDGUDID

Active European Union

Ref 75001042

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10850044310545 UDI-DIDate10 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number0850685007750092_IVD3Z Basic UDI-DIDate21 Nov 2023RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Thermo Scientific X2T IVD-MD EUDAMED
Thermo Scientific GUDID
Generic Name
General-purpose centrifuge IVD
Device Name
GP1 Pro
Model / Ref / Catalog
75001042, Thermo Scientific X2T IVD-MD
Primary DI / UDI-DI
10850044310545
Basic UDI-DI
0850685007750092_IVD3Z
Direct Marketing DI
10850044310545
FDA Product Code
JQC
EMDN Code
W02069003 Centrifuges
GMDN Term
General-purpose centrifuge IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2050
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
75001042
GUDID
Thermo Scientific X2T IVD-MD
Device ClassEUDAMED
Class A
GUDID
Class I

Other devices from Thermo Electron LED GmbH

See all devices from Thermo Electron LED GmbH →

Properties

  • Surgical Instrument
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No