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Cellenis® C_EXOME10U

by Estar Technologies Ltd

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290015874489 UDI-DI Date14 Jul 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  • Withdrawn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
Cellenis®
Generic Name
Haematological concentrate system preparation kit, platelet concentration
Model / Ref / Catalog
C_EXOME10U
Primary DI / UDI-DI
07290015874489
GMDN Term
Haematological concentrate system preparation kit, platelet concentration
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Other devices from Estar Technologies Ltd

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Properties

  • Sterile
  • Single Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No