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EdgeFlow UH10E UH10101E

by EdgeCare Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809887550187 UDI-DIDate30 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
EdgeFlow UH10E
Generic Name
Bladder volume ultrasound imaging system
Model / Reference
UH10101E
Primary DI / UDI-DI
08809887550187
510(k) Number
FDA Product Code
ITX, IYO, QIH
GMDN Term
Bladder volume ultrasound imaging system
Device Class
Class II
Regulation Number
892.1570, 892.1560, 892.2050
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K231677)

Other devices from EdgeCare Inc.

See all devices from EdgeCare Inc. →

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