Manufacturer

Medikro

FinlandLegal entities : Medikro Oy

Markets : Finland · Sweden · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 2 · class II · latest in 2015 · see on the FDA website

Public contracts won : Sweden 2

4 categories, 26 models including 26 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Clinical/diagnostic spirometers	Z12150101	M948893/42 M9488-E93/42 M9488-WA93/42 M9488-WA293/42 M949293/42 6 others M9492-E93/42 M949793/42 M9497-E93/42 Medikro Duo M9497 Medikro Primo M9492 Medikro Pro M9488	IIa MDR, 93/42	EUDAMED record Report an error
Spirometry instruments - consumables	Z12150185	Disposable Flow Transducer M9242-WA2 refs93/42 Disposable Flow Transducer M9256-MM2 refs93/42 Disposable Flow Transducer M9256-WA3 refs93/42 M92533 refs Medikro Pressure Tube M92643 refs 5 others SpiroSafe Disposable Flow Transducer M924293/42 SpiroSafe Disposable Flow Transducers M924293/42 SpiroSafe Disposable Flow Transducers M9242-B2 refs93/42 SpiroSafe Disposable Flow Transducers M92563 refs SpiroSafe Disposable Flow Transducers M9256-A93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Spirometry instruments - other	Z12150199	Medikro Calibration Syringe Outlet Port Adapter Kit M94743 refs Medikro Grip M912272 refs Medikro® Ambi M94892 refs	I MDR	EUDAMED record Report an error
Spirometry instruments - medical device software	Z12150192	M983193/42 Medikro Spirometry Software M9831	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.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.