Manufacturer

Icare Finland

FinlandLegal entities : Icare Finland Oy

Markets : Finland · Lithuania · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 7 · class II · latest in 2024 · see on the FDA website

8 categories, 24 models including 17 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Tonometers	Z12120122	iCare HOME2 TA0233 refs iCare IC100 TA0113 refs iCare IC1000 TA032 iCare IC200 TA0313 refs iCare ST500 TA043 refs 2 others iCare HOME TA02293/42 (no longer marketed) iCare TA01i93/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Various ophtalmology instruments - hardware accessories	Z12129080	IC1000 ChargingCradle TX04 IC1000 SmartCradle TX03 ST500 Remote TR01 ST500 SmartCradle TX02	I MDR	EUDAMED record Report an error
Ophtalmology assessments and diagnosis instruments - software accessories	Z12120182	iCare CLINIC TS02 iCare EXPORT TS03 iCare PATIENT2 TS05 iCare LINK TS0193/42 (no longer marketed) iCare PATIENT TS0493/42 (no longer marketed)	I, IIa MDR, 93/42	EUDAMED record Report an error
Ophtalmology assessments and diagnosis instruments - consumables	Z12120185	iCare TP01 Probes2 refs iCare TP022 Probes2 refs iCare TP03 Probes93/42 (no longer marketed)	I, IIa MDR, 93/42	EUDAMED record Report an error
Various pneumology and respiratory physiopathology instruments - other	Z12159099	Ventica Shirt, 90-100 cm IPCL013 refs Ventica IPREC0193/42 (no longer marketed)	I, IIa MDR, 93/42	EUDAMED record Report an error
Ophthalmological instrument stands	Z12129001	ST500 Adapter TD01	I MDR	EUDAMED record Report an error
Various pneumology and respiratory physiopathology instruments - consumables	Z12159085	Ventica Electrodes IPEL01	I MDR	EUDAMED record Report an error
Various pneumology and respiratory physiopathology instruments - medical device software No model still on the market	Z12159092	Ventica Analytics RSP0193/42 (no longer marketed)	IIa 93/42	EUDAMED record Report an error

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