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Kosmos Bridge

by EchoNous

Part of a family of 31 devices: see the family page

Ref P006030

Kosmos Bridge (P006030) is a device classified as Class IIa in the EU and Class II in the US made by EchoNous, registered in EUDAMED on 29 Oct 2021 (Basic UDI-DI 93532780KOSMOSWH), cleared under FDA 510(k) K193518 on 26 Mar 2020 and listed in FDA GUDID since 6 May 2020 (UDI-DI 09353278000120), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193518

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number93532780KOSMOSWH Basic UDI-DI 09353278000120UDI-DIDate29 Oct 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number09353278000120 UDI-DI Date6 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193518 Date26 Mar 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 93532780KOSMOSWH registered 29 Oct 2021 Active
  • FDA 510(k) K193518 decided 26 Mar 2020 Active
  • FDA GUDID UDI-DI 09353278000120 listed 6 May 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K193518
  2. Listed FDA GUDID 09353278000120
  3. Registered EUDAMED 93532780KOSMOSWH

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Ultrasound/electrocardiograph/stethoscope unit
Device name
Kosmos
Model / reference
P006030
Description
Diagnostic ultrasound system with integrated electronic stethoscope and electrocardiograph Ultrasound/ electrocardiograph/ stethoscope unit
Primary DI / UDI-DI
09353278000120
Basic UDI-DI
93532780KOSMOSWH
510(k) Number
FDA product code
IYO, IYN, DQD, DPS
EMDN code
Z11040106 Handheld ultrasound scanners
GMDN term
Ultrasound/electrocardiograph/stethoscope unit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560, 892.1550, 870.1875, 870.2340
EU registration type
Standard device
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000004161
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under HANDHELD ULTRASOUND SCANNERS.

Other devices from EchoNous

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)