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EchoNous

United States·US-MF-000004161

Last updated September 17, 2026

Information

Country: United States
Address: 8310 154th Ave NE, Redmond, United States
Website: echonous.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Joshua Kim
EUDAMED SRN: US-MF-000004161
FDA FEI Number: 3013757696
DUNS Number: —

Catalogue (65)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Kosmos OTS iOS	iOS 4.X	FDA UDI	Class II	Unknown
EchoNous Bladder Probe	P005600	FDA UDI	Class II	Active
Mobile Stand	P005149	FDA UDI	Class II	Active
Uscan System	P003965	FDA UDI	Class II	Active
EchoNous System	P006210	FDA UDI	Class II	Active
Uscan Sector Probe	P003951	FDA UDI	Class II	Active
Uscan Mobile Stand	P006024	FDA UDI	Class II	Active
Uscan Sector Probe - Refurbished	R003951	FDA UDI	Class II	Active
Uscan System	P005195	FDA UDI	Class II	Active
Uscan Linear Probe	P005194	FDA UDI	Class II	Active
EchoNous System (Refurbished)	R006210	FDA UDI	Class II	Active
EchoNous Bladder Probe - Refurbished	R005600	FDA UDI	Class II	Active
Hub - Refurbished	R005324	FDA UDI	Class II	Active
EchoNous System (Refurbished)	R006705	FDA UDI	Class II	Active
Binaural Headset - Refurbished	R006115	FDA UDI	Class II	Active
Uscan Mobile Stand	P005425	FDA UDI	Class II	Active
Kosmos OTS iOS Software Package	P007639	FDA UDI	Class II	Active
Uscan System - Refurbished	R003965	FDA UDI	Class II	Active
Uscan Sector Probe (Japan)	P003994	FDA UDI	Class II	Active
Kosmos Accessories - US - Refurbished	R006208	FDA UDI	Class II	Active
Kosmos ECG Patient Cable - US	P005779	FDA UDI	Class II	Active
EchoNous Samsung S8 Tablet with Software	P007635	FDA UDI	Class II	Active
Hub	P005324	FDA UDI	Class II	Active
Uscan System - Refurbished (Japan)	R004104	FDA UDI	Class II	Active
Uscan System (Japan)	P004104	FDA UDI	Class II	Active
Kosmos OTS Android Linear	P007213	FDA UDI	Class II	Active
EchoNous Samsung S8 Tablet with Software (Refurbished)	R007635	FDA UDI	Class II	Active
EchoNous System - Refurbished	R005195	FDA UDI	Class II	Active
Kosmos	P008041	FDA UDI	Class II	Active
Kosmos	P008042	FDA UDI	Class II	Active
Kosmos UP	P006598	FDA UDI	Class I	Active
Kosmos Accessories - US	P006208	FDA UDI	Class II	Active
Uscan Linear Probe	R005194	FDA UDI	Class II	Active
EchoNous System	P006705	FDA UDI	Class II	Active
Uscan Sector Probe - Refurbished (Japan)	R003994	FDA UDI	Class II	Active
Kosmos OTS Android	P007893	EUDAMED	Class IIa	Active
Kosmos Bridge	P006030	EUDAMEDFDA UDI	Class IIa	Active
Kosmos Torso (Refurbished)	R006025	EUDAMEDFDA UDI	Class IIa	Active
Kosmos Accessories-International	P006105	EUDAMEDFDA UDI	Class IIa	Active
AI Station 2	P006200	EUDAMEDFDA UDI	Class I	Active
Kosmos	K242321	FDA 510(k)	Class II	Active
Kosmos	K212100	FDA 510(k)	Class II	Active
Kosmos	K233826	FDA 510(k)	Class II	Active
Uscan	K181574	FDA 510(k)	Class II	Active
Kosmos	K193518	FDA 510(k)	Class II	Active
Kosmos OTS iOS	P007944	EUDAMEDFDA UDI	Class IIa	Active
Kosmos Hub (Refurbished)	R006966	EUDAMEDFDA UDI	Class I	Active
Kosmos	P008388	EUDAMED	Class IIa	Active
Kosmos ECG Patient Cable – International	P006186	EUDAMEDFDA UDI	Class IIa	Active
Kosmos	P008791	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Advena Limited MT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 9, 2024	Z-2325-2024	—	open, classified	Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.