DigiDop

FDA UDI

Class II (US FDA UDI)

by Newman Medical

Identity

Trade Name: DigiDop FDA UDI
Generic Name: Noninvasive vascular ultrasound system probe FDA UDI
Device Name: Audio PPG vascular probe (probe only) FDA UDI
Model / Reference: DPPG FDA UDI
Description: Audio PPG vascular probe (probe only) FDA UDI

Identifiers

Catalog Number: DPPG FDA UDI
Primary DI / UDI-DI: 00852785008593 FDA UDI
510(k) Number: K090465 FDA UDI
FDA Product Code: JAF FDA UDI
GMDN Term: Noninvasive vascular ultrasound system probe 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 probe

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

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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

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Manufacturer

Manufacturer: Newman Medical

Sources (1)

FDA UDI b3386e53-c694-492e-98eb-797b415be7a4 37 fields · synced Jun 1, 2026