FIZE kUO Disposable Pediatrics kit, Urinemeter

FDA UDI

Class II (US FDA UDI)

by Fize Research Ltd

Identity

Trade Name: FIZE kUO Disposable Pediatrics kit, Urinemeter FDA UDI
Generic Name: Urine monitoring system FDA UDI
Device Name: FIZE kUO Disposable Pediatrics kit, Urinemeter catalog number of 1 pc: FI-KT00-KU01-0011 FIZE kUO Disposable Pediatrics kit,Urinemeter catalog number of 20 pcs: FI-FG00-KU03-0006 FDA UDI
Model / Reference: G2 FDA UDI
Description: FIZE kUO Disposable Pediatrics kit, Urinemeter catalog number of 1 pc: FI-KT00-KU01-0011 FIZE kUO Disposable Pediatrics kit,Urinemeter catalog number of 20 pcs: FI-FG00-KU03-0006 FDA UDI

Identifiers

Catalog Number: FI-KT00-KU01-0011 FDA UDI
Primary DI / UDI-DI: 07290019239284 FDA UDI
FDA Product Code: EXY FDA UDI
GMDN Term: Urine monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Urine monitoring system

FIZE kUO Disposable Pediatrics kit, Urinemeter by Fize Research Ltd — 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: Fize Research Ltd

Sources (1)

FDA UDI bbeb7c76-25aa-4ab7-ab9b-8fbf6d1fbcd9 34 fields · synced Jun 1, 2026