EchoGo

FDA UDI

Class II (US FDA UDI)

by Ultromics, Ltd.

Identity

Trade Name: EchoGo FDA UDI
Generic Name: Ultrasound imaging system application software FDA UDI
Model / Reference: Pro FDA UDI

Identifiers

Primary DI / UDI-DI: 05060634690010 FDA UDI
510(k) Number: K201555 FDA UDI
FDA Product Code: POK FDA UDI
GMDN Term: Ultrasound imaging system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac mapping system application software Ultrasound imaging system application software

EchoGo by Ultromics, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ultromics, Ltd.

Sources (1)

FDA UDI 590a051c-5af8-475b-afd1-1bd592d73f53 33 fields · synced May 29, 2026