Chummie

FDA UDI

Class II (US FDA UDI)

by Theos Medical Systems, Inc.

Identity

Trade Name: Chummie FDA UDI
Generic Name: Incontinence sensor/alarm FDA UDI
Device Name: A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability, and may be used in the home or a healthcare facility. FDA UDI
Model / Reference: TCE25B FDA UDI
Description: A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability, and may be used in the home or a healthcare facility. FDA UDI

Identifiers

Primary DI / UDI-DI: 00854950002177 FDA UDI
FDA Product Code: KPN FDA UDI
GMDN Term: Incontinence sensor/alarm 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

Yes

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

Category: Incontinence sensor/alarm

Chummie by Theos Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Malem — MALEM MEDICAL LIMITED · Class II
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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: Theos Medical Systems, Inc.

Sources (1)

FDA UDI 4a83b0b4-f2c5-4899-bca6-c068f2da12bf 33 fields · synced May 30, 2026