Manufacturer

Cosmed

France, Italy, United StatesLegal entities : COSMED France, COSMED Srl, COSMED USA, Inc.

Markets : Denmark · France · Germany · Ireland · Italy · Netherlands · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 11 · class II · latest in 2020 · see on the FDA website

Public contracts won : France 21 · Italy 6 · Germany 2 · Netherlands 2 · Denmark 1 · Ireland 1

EU representative : Advena Limited (Malta)

6 categories, 20 models including 20 on the market, 3 countries

Category	EMDN code	Registered models	Class	Contact
Body impedance analysers	Z12099001	Measuring cables FR(EX)Z1CAB2 refs Starvac Diag3 refs Starvac Diag Software Starvac Diag System Z-Hydra software 4 others Z-Hydra System Z-Métrix system Z-Métrix Z1 software Z-Métrix Z2 software	I, IIa MDR	EUDAMED record Report an error
Clinical/diagnostic spirometers	Z12150101	microQuark Q Quark PFT Quark series3 refs Quark PFT1 Quark series2 refs	IIa MDR	EUDAMED record Report an error
Body plethysmographs	Z12159007	BOD POD Body Composition System3 refs Q-Box Quark series	I, IIa MDR	EUDAMED record Report an error
Stress analysis systems	Z12050101	K5 Quark CPET Quark series3 refs	IIa MDR	EUDAMED record Report an error
Various pneumology and respiratory physiopathology instruments - other	Z12159099	Q-i2m Quark series2 refs Quark PFT ergo Quark series2 refs	IIa MDR	EUDAMED record Report an error
Metabolism equipment	Z1203020404	Q-NRG series3 refs	IIa MDR	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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