ICARE FINLAND OY

Address:Ayritie 22,Vantaa Uusimaa,FI

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Tonometer, Manual (HKY) (10) Tonometer, Ac-Powered (HKX) (6)

Premarket Exempt

Clear

Icare TA01i - 06430033850060 Catalog Number :

Device Description : The Icare tonometer is used in the diagnosis, follow up and screening of glaucom The Icare tonometer is used in the diagnosis, follow up and screening of glaucoma. It is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic.The Icare tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.

Device Class : 2

Duns Number: 651755092

Premarket Exempt : No

Product Code : HKX, HKY

Prescription Use : Yes

Device Count : 1

Icare HOME tonometer - 06430033850237 Catalog Number :

Device Class : 2

Duns Number: 651755092

Premarket Exempt : No

Product Code : HKX, HKY

Prescription Use : Yes

Device Count : 1

Icare ic100 - 06430033850473 Catalog Number :

Device Description : The Icare ic100 tonometer is based on induction-based rebound method, which allo The Icare ic100 tonometer is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidlyand without an anesthetic. The Icare ic100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

Device Class : 2

Duns Number: 651755092

Premarket Exempt : No

Product Code : HKX, HKY

Prescription Use : Yes

Device Count : 1

Icare tonometer probes - 06430033850565 Catalog Number :

Device Class : 2

Duns Number: 651755092

Premarket Exempt : No

Product Code : HKX, HKY

Prescription Use : Yes

Device Count : 1

Probes for HOME - 06430033850626 Catalog Number :

Device Description : Single unit blister package

Device Class : 2

Duns Number: 651755092

Premarket Exempt : No

Product Code : HKX, HKY

Prescription Use : Yes

Device Count : 1

Probes for HOME - 06430033850947 Catalog Number :

Device Description : Sales package 20pcs of TP022 probes

Device Class : 2

Duns Number: 651755092

Premarket Exempt : No

Product Code : HKX, HKY

Prescription Use : Yes

Device Count : 1

Icare CLINIC - 06430033850961 Catalog Number :

Device Description : Icare CLINIC

Device Class : 2

Duns Number: 651755092

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 1

Icare EXPORT - 06430033850978 Catalog Number :

Device Description : Icare EXPORT

Device Class : 2

Duns Number: 651755092

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 1

Icare PATIENT - 06430033850985 Catalog Number :

Device Description : Icare PATIENT

Device Class : 2

Duns Number: 651755092

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 1

Icare ic200 - 06430033851036 Catalog Number :

Device Description : The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic200 tonometer measures the IOP by utilizing the rebound method. The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye. Icare ic200 allows IOP measurement of patients in all positions between sitting and supine positions. IOP measurement result can be transferred to printer or to a PC via Bluetooth connection.

Device Class : 2

Duns Number: 651755092

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 1

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