DigiDop

FDA UDI

Class II (US FDA UDI)

by Newman Medical

Identity

Trade Name: DigiDop FDA UDI
Generic Name: Noninvasive vascular ultrasound system FDA UDI
Device Name: DigiDop 701, Display w recharger, 8MHZ VASCULAR FDA UDI
Model / Reference: DD-701-D8 FDA UDI
Description: DigiDop 701, Display w recharger, 8MHZ VASCULAR FDA UDI

Identifiers

Catalog Number: DD-701-D8 FDA UDI
Primary DI / UDI-DI: 00852785008234 FDA UDI
510(k) Number: K090465 FDA UDI
FDA Product Code: JAF FDA UDI
GMDN Term: Noninvasive vascular ultrasound system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1540 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

Category: Noninvasive vascular ultrasound system

DigiDop by Newman Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive vascular ultrasound system.

Summit Doppler — CooperSurgical, Inc. · Class II
Summit Doppler — CooperSurgical, Inc. · Class II
NovaGuide™ Intelligent Ultrasound System — Novasignal Corporation · Class II
Vave — VAVE HEALTH INC · Class II
TRIA II Display Doppler — CooperSurgical, Inc. · Class II
Summit Doppler — CooperSurgical, Inc. · Class II
A.M.I. HAL Handle — AMI Agency for Medical Innovations GmbH · Class II
SMARTNEEDLE — TELEFLEX INCORPORATED · Class II

Cleared under the same submission

K090465 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Newman Medical

Sources (1)

FDA UDI ad9b38e4-e00e-4cb2-9653-4dabd49f21ab 37 fields · synced Jun 1, 2026