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XR-10 XR-Series Automated HematologyAnalyzer CF730361

by Sysmex Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04987562505319 UDI-DI Date11 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
XR-10 XR-Series Automated HematologyAnalyzer
Generic Name
Haematological cell analyser IVD
Model / Reference
CF730361
Primary DI / UDI-DI
04987562505319
FDA Product Code
GKZ
GMDN Term
Haematological cell analyser IVD
Device Class
Class II
Regulation Number
864.5220
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No