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Eko Mobile App Android International

FDA UDI

Class I (US FDA UDI)

by Eko Devices, Inc.

Identity

Trade Name
Eko Mobile App Android International FDA UDI
Generic Name
Medical equipment clinical data interfacing software FDA UDI
Device Name
Eko mobile app for android international platforms for use with Eko medical devices. FDA UDI
Model / Reference
com.ekodevices.android.intl FDA UDI
Description
Eko mobile app for android international platforms for use with Eko medical devices. FDA UDI

Identifiers

Primary DI / UDI-DI
00850010298061 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Medical equipment clinical data interfacing software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment clinical data interfacing software

Eko Mobile App Android International by Eko Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment clinical data interfacing software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eko Devices, Inc.

Sources (1)

  • FDA UDI dfa4beb4-f93c-47c2-b9b0-92355835dd53 33 fields · synced May 30, 2026