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Kosmos

by EchoNous

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

Ref P008791, P006632

Kosmos (P008791) is a device classified as Class IIa in the EU and Class II in the US made by EchoNous, cleared under FDA 510(k) K242321 on 25 Apr 2025 (1 earlier submission), registered in EUDAMED on 29 Oct 2021 (Basic UDI-DI 93532780KOSMOSWH) and listed in FDA GUDID since 26 Feb 2021 (UDI-DI 09353278000878), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242321

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK242321 Date25 Apr 2025DecidedStatusActive
European UnionCE/MDR EUDAMED Number93532780KOSMOSWH Basic UDI-DI Date29 Oct 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number09353278000878 UDI-DI Date26 Feb 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • FDA 510(k) K242321 decided 25 Apr 2025 Active· +1 more in the status table
  • EUDAMED Basic UDI-DI 93532780KOSMOSWH registered 29 Oct 2021 Active
  • FDA GUDID UDI-DI 09353278000878 listed 26 Feb 2021 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K193518
  2. Listed FDA GUDID 09353278000878
  3. Registered EUDAMED 93532780KOSMOSWH
  4. Cleared FDA 510(k) K242321

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  • Withdrawn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

Trade name
Kosmos EUDAMED
Kosmos Torso-One – USB EUDAMED
Kosmos Torso-One - USB GUDID
Kosmos OTS iOS Software Package (5.0) GUDID
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Model / Ref / Catalog
P008791, P006632, v5.0
Primary DI / UDI-DI
09353278000878, 09353278000502
Basic UDI-DI
93532780KOSMOSWH
510(k) Number
FDA product code
ITX, IYN, IYO
EMDN code
Z11040106, Z110402010301
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570, 892.1550, 892.1560
EU registration type
Standard device
EU market of registration
Denmark
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 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL.

Other devices from EchoNous

See all devices from EchoNous →

Properties

  • Prescription use
  • Lot / batch number NoGUDIDYesGUDID
  • Serial number YesGUDIDNoGUDID
  • Manufacturing date YesGUDIDNoGUDID
Other properties (21, all answered No)