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Eko App Windows

FDA UDI

Class I (US FDA UDI)

by Eko Devices, Inc.

Identity

Trade Name
Eko App Windows FDA UDI
Generic Name
Medical equipment clinical data interfacing software FDA UDI
Device Name
Windows PC Application for use with Eko products. FDA UDI
Model / Reference
1.2.4 FDA UDI
Description
Windows PC Application for use with Eko products. FDA UDI

Identifiers

Primary DI / UDI-DI
00863609000358 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment clinical data interfacing software

Eko App Windows 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 9e7c0a88-0c68-4a22-bc19-a34825397c47 33 fields · synced May 31, 2026