Manufacturer

Nox Medical

Iceland

Markets : Bulgaria · Denmark · Finland · France · Germany · Iceland · Italy · Netherlands · Norway · Spain · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 3 · class I, II · latest in 2019 · see on the FDA website

4 categories, 21 models including 21 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Polysomnographs	Z12100501	A1s Recorder APSG1SEU93/42 A1s System NOX-A1S_EUF C1s Kit EU NOX-C1SKIT193/42 Nox A1S SAS kit Nox C1 Access Point NOX-SCOM193/42 3 others Nox C1 Kit NOX-C1KIT193/42 Nox T3s System, EU NOX-T3S_EUF T3s Recorder EU ASDB1SEU93/42	IIa MDR, 93/42	EUDAMED record Report an error
Polysomnography instruments - hardware accessories	Z12100580	NOX - SAS Head Cable ESNAP10SASLM3 refs Nox A1® EEG 5 Lead Gold Electrode Cable A1 EEG 5 lead gold cups Nox A1® EEG Head Cable3 refs Nox Abdomen Cable2 refs Nox Mini USB Cable	I MDR	EUDAMED record Report an error
Polysomnography instruments - consumables	Z12100585	Nox Filter Tube Connector Nox Nasal Pressure Cannula with Filter93/42 Nox Nasal Pressure Cannula with Filter NOX-MDR_CANAF40 Nox RIP Belts Disposable - Large3 refs	I, IIa MDR, 93/42	EUDAMED record Report an error
Polysomnography instruments - software accessories	Z12100582	DeepRESP NOX-NOXTURNAL_APP93/42 Noxturnal Language Pack CD NOXTURNAL_LP_CD93/42 Noxturnal® NOX-NOXT_CD93/42	IIa MDR, 93/42	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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