proudP SU-UFM-001

by Soundable Health, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00860006184902 UDI-DI	Date15 Feb 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: proudP
Generic Name: Home uroflowmetry software
Model / Reference: SU-UFM-001

Primary DI / UDI-DI: 00860006184902
FDA Product Code: EXY
GMDN Term: Home uroflowmetry software

Device Class: Class II
Regulation Number: 876.1800
GUDID distribution status: In Commercial Distribution

Other devices from Soundable Health, Inc.

proudP SU-UFM-001

Class II

Properties

Prescription Use
Over-the-Counter
Premarket Exempt

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No