iCare IC200

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref Standard A2Model TA031Ref Standard A (item 250A)

by Icare Finland Oy

Identity

Trade Name: iCare IC200 EUDAMED
Device Name: iCare IC200 EUDAMED
Model / Reference: TA031 EUDAMED
Standard A2 EUDAMED
Standard A (item 250A) EUDAMED

Identifiers

Primary DI / UDI-DI: 06430033851746 EUDAMED
06430033851647 EUDAMED
06430033852187 EUDAMED
Basic UDI-DI: 643003385TA031XB EUDAMED
Direct Marketing DI: 06430033851746 EUDAMED
06430033851647 EUDAMED
06430033852187 EUDAMED
EMDN Code: Z12120122 TONOMETERS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Finland EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

iCare IC200 by Icare Finland Oy — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K220852	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K190316	Class IIa	Active
EUDAMED	European Union	CE/MDR	643003385TA031XB	Class IIa	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Icare Finland Oy
EUDAMED SRN: FI-MF-000000501

Sources (4)

EUDAMED 15591c7a-00dc-4924-9665-dce587504fbd 61 fields · synced Aug 5, 2026
EUDAMED f5d5710d-5d37-45d4-8fbf-5dd88987573d 61 fields · synced May 18, 2026
EUDAMED 59f0cff8-4ca6-4bc9-83a4-ee075aeff555 61 fields · synced May 19, 2026
FDA 510(k) K220852 1 fields · synced May 18, 2026