ES100X MiniDop

FDA UDI

Class II (US FDA UDI)

by Koven Technology, Inc.

Identity

Trade Name: ES100X MiniDop FDA UDI
Generic Name: Vascular ultrasound system control unit FDA UDI
Device Name: Handheld Doppler FDA UDI
Model / Reference: ES100X FDA UDI
Description: Handheld Doppler FDA UDI

Identifiers

Catalog Number: ES100X FDA UDI
Primary DI / UDI-DI: 00894912002029 FDA UDI
510(k) Number: K840542 FDA UDI
FDA Product Code: JOP FDA UDI
GMDN Term: Vascular ultrasound system control unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2880 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Vascular ultrasound system control unit

ES100X MiniDop by Koven Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K840542 also covers:

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: Koven Technology, Inc.

Sources (1)

FDA UDI bae095e4-f6d4-467b-9c46-cdcc8f50bcb9 36 fields · synced Jun 9, 2026