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Smartdop 30EX

FDA UDI

Class II (US FDA UDI)

by Koven Technology, Inc.

Identity

Trade Name
Smartdop 30EX FDA UDI
Generic Name
Noninvasive vascular ultrasound system, line-powered FDA UDI
Device Name
Bidirectional recording Doppler with automatic cuff inflator. FDA UDI
Model / Reference
Smartdop 30EX FDA UDI
Description
Bidirectional recording Doppler with automatic cuff inflator. FDA UDI

Identifiers

Catalog Number
Smartdop 30EX FDA UDI
Primary DI / UDI-DI
00894912002098 FDA UDI
510(k) Number
K942613 FDA UDI
FDA Product Code
DPW FDA UDI
GMDN Term
Noninvasive vascular ultrasound system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2100 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, line-powered

Smartdop 30EX 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, line-powered.

Cleared under the same submission

K942613 also covers:

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 c58783d1-eb4c-47a3-a667-1cc5102b8a89 36 fields · synced Jun 9, 2026