Skip to content

EdgeFlow UH10

by Edgecare Inc. EUDAMED510(k)GUDID

Active United States and European Union

Ref UH10101Model EdgeFlow UH10, EdgeFlow UH10S, EdgeFlow UH10L

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880988755ECUXJ Basic UDI-DIDate6 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809887550002 UDI-DIDate8 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK231677 Date6 Mar 2024IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Bladder volume ultrasound imaging system
Model / Reference
EdgeFlow UH10, EdgeFlow UH10S, EdgeFlow UH10L, UH10101
Primary DI / UDI-DI
08809887550002
Basic UDI-DI
880988755ECUXJ
510(k) Number
FDA Product Code
ITX, IYO, QIH
EMDN Code
Z11040106 Handheld ultrasound scanners
GMDN Term
Bladder volume ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1570, 892.1560, 892.2050
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000039973
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from EdgeCare Inc.

See all devices from EdgeCare Inc. →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No