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Rotanode Xrc-5552X

by Canon Electron Tubes & Devices Co., Ltd.

Model X-ray Tube Assembly

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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
United StatesGUDID listing GUDID Number04580274413721 UDI-DI Date12 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number45802744133523659295537M9 Basic UDI-DI 04580274413721UDI-DIDate22 Apr 2025RegisteredStatusActive

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Rotanode Xrc-5552X EUDAMED
Rotating Anode X-ray Tube Assembly GUDID
Generic Name
X-ray tube housing assembly, diagnostic
Model / Reference
X-ray Tube Assembly EUDAMED
XRC-5552X GUDID
Primary DI / UDI-DI
04580274413721
Basic UDI-DI
45802744133523659295537M9
FDA Product Code
ITY
EMDN Code
Z11039012 X-ray tube assembly
GMDN Term
X-ray tube housing assembly, diagnostic
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
892.1760
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
X-ray Tube Assembly
GUDID
XRC-5552X
Device ClassEUDAMED
Class IIb
GUDID
Class I

Manufacturer details

EUDAMED SRN
JP-MF-000009481
Authorised representative
Canon Medical Components Europe B.V. NL-AR-000029305

Other devices from Canon Electron Tubes & Devices Co., Ltd.

See all devices from Canon Electron Tubes & Devices Co., Ltd. →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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
  • Lot / Batch Number: No
  • Expiration Date: No