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BiDop 3

FDA UDI

Class II (US FDA UDI)

by Koven Technology, Inc.

Identity

Trade Name
BiDop 3 FDA UDI
Generic Name
Noninvasive vascular ultrasound system FDA UDI
Device Name
Bidirectional Doppler with waveform display. FDA UDI
Model / Reference
BiDop 3 FDA UDI
Description
Bidirectional Doppler with waveform display. FDA UDI

Identifiers

Catalog Number
ES-100V3 FDA UDI
Primary DI / UDI-DI
00894912002043 FDA UDI
510(k) Number
K954397 FDA UDI
FDA Product Code
DPW FDA UDI
JOP FDA UDI
GMDN Term
Noninvasive vascular ultrasound system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2100 FDA UDI
870.2880 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

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Noninvasive vascular ultrasound system

BiDop 3 by Koven Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive vascular ultrasound system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Koven Technology, Inc.

Sources (1)

  • FDA UDI 16643e2f-20a9-4272-b917-e578e2c2bedf 36 fields · synced Jun 9, 2026