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Na Xct 3000

by Stratec Medizintechnik GmbH

Ref 923000

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04260491560025 Basic UDI-DI 04260491560025UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260491560025 UDI-DI Date26 Apr 2017ListedStatusListed GUDID: in commercial distribution

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 found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Xct 3000
Generic Name
Limited-view-field CT system
Model / Ref / Catalog
923000 EUDAMED
XCT 3000 GUDID
Primary DI / UDI-DI
04260491560025
Basic UDI-DI
B-04260491560025
510(k) Number
FDA Product Code
KGI
EMDN Code
Z11900103 X–ray bone densitometers
GMDN Term
Limited-view-field CT system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1170
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
923000
GUDID
XCT 3000
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Limited-view-field CT system

Cleared under the same submission (K983273)

Other devices from Stratec Medizintechnik GmbH

Properties

  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No