Utopia NE

FDA UDI

Class II (US FDA UDI)

by Innomed Technologies

Identity

Trade Name: Utopia NE FDA UDI
Generic Name: CPAP/BPAP face mask, single-use FDA UDI
Device Name: Utopia NE Face Mask - Medium (with Black Headgear) FDA UDI
Model / Reference: MD FDA UDI
Description: Utopia NE Face Mask - Medium (with Black Headgear) FDA UDI

Identifiers

Catalog Number: UTO273A FDA UDI
Primary DI / UDI-DI: M694UTO273A1 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: CPAP/BPAP face mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: CPAP/BPAP face mask, single-use

Utopia NE by Innomed Technologies — 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: Innomed Technologies

Sources (1)

FDA UDI 9ba28f52-2ddf-4d72-8110-59b13453c6ae 36 fields · synced Jun 1, 2026