Nox T3s System

FDA UDI

Class II (US FDA UDI)

by Nox Medical ehf.

Identity

Trade Name: Nox T3s System FDA UDI
Generic Name: Polysomnography analyser FDA UDI
Model / Reference: NOX-T3S_USF FDA UDI

Identifiers

Catalog Number: 511112 FDA UDI
Primary DI / UDI-DI: 15694311111467 FDA UDI
510(k) Number: K082113 FDA UDI
FDA Product Code: MNR FDA UDI
DQA FDA UDI
GMDN Term: Polysomnography analyser FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2375 FDA UDI
870.2700 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

MRI Safety

MR Unsafe FDA UDI

Category: Polysomnography analyser

Nox T3s System by Nox Medical ehf. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K082113 also covers:

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: Nox Medical ehf.

Sources (1)

FDA UDI 4f5a5437-f106-44cc-98fb-631ccc2f2b92 35 fields · synced May 31, 2026