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Atmos UD-A46215

by Bioengineering Laboratories SRL GUDID

Withdrawn United States

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberE261UDA462150 UDI-DIDate10 Oct 2024ListedStatusWithdrawn

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Atmos
Generic Name
Urological irrigation set
Model / Reference
UD-A46215
Primary DI / UDI-DI
E261UDA462150
FDA Product Code
EXQ
GMDN Term
Urological irrigation set
Device Class
Class II
Regulation Number
876.1620
Commercial Distribution
Not in Commercial Distribution
Size
Outer Diameter — 6 Millimeter

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No