Urostym

FDA UDI

Class II (US FDA UDI)

by Laborie Medical Technologies Canada ULC

Identity

Trade Name: Urostym FDA UDI
Generic Name: Biofeedback system FDA UDI
Model / Reference: PRO180 FDA UDI

Identifiers

Primary DI / UDI-DI: 00627825006019 FDA UDI
FDA Product Code: HIR FDA UDI
KPI FDA UDI
GMDN Term: Biofeedback system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1425 FDA UDI
876.5320 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

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

Yes

FDA UDI

Category: Biofeedback system

Urostym by Laborie Medical Technologies Canada ULC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Laborie Medical Technologies Canada ULC

Sources (1)

FDA UDI a4cf4cd8-cd72-4fd0-a3b5-4f14ceb9f51e 32 fields · synced Jun 6, 2026