Tena

FDA UDI

Class II (US FDA UDI)

by Essity Hygiene and Health AB

Identity

Trade Name: TENA FDA UDI
Generic Name: Urine flowmeter, reusable FDA UDI
Device Name: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA SmartCare Sensor Strip. It is an assortment of wetness indicators to be used as an accessory to an absorbent hygiene product used by dependent individuals suffering from incontinence problems. FDA UDI
Model / Reference: SmartCare Sensor Strip medium FDA UDI
Description: The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA SmartCare Sensor Strip. It is an assortment of wetness indicators to be used as an accessory to an absorbent hygiene product used by dependent individuals suffering from incontinence problems. FDA UDI

Identifiers

Primary DI / UDI-DI: 00768702912822 FDA UDI
FDA Product Code: KPN FDA UDI
GMDN Term: Urine flowmeter, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.2040 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Urine flowmeter, reusable

Tena by Essity Hygiene and Health AB — 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: Essity Hygiene and Health AB

Sources (1)

FDA UDI 9a2de20f-3819-4950-b021-1c2f73715c3b 34 fields · synced May 30, 2026