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iCare HOME2
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 260A3Model TA023Ref Standard A4Ref 260A1Ref Standard A2Ref 260A4Ref 260A2Ref Standard A1Ref WEB-Standard A1
Identity
- Trade Name
- iCare HOME2 EUDAMED
- Device Name
- iCare HOME2 EUDAMED
- Model / Reference
- TA023 EUDAMED260A3 EUDAMEDStandard A4 EUDAMED260A1 EUDAMEDStandard A2 EUDAMED260A4 EUDAMED260A2 EUDAMEDStandard A1 EUDAMEDWEB-Standard A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033852217 EUDAMED06430033851852 EUDAMED06430033852194 EUDAMED06430033851388 EUDAMED06430033852224 EUDAMED06430033852200 EUDAMED06430033851067 EUDAMED06430033851371 EUDAMED
- Basic UDI-DI
- 643003385TA023XC EUDAMED
- Direct Marketing DI
- 06430033852217 EUDAMED06430033851852 EUDAMED06430033852194 EUDAMED06430033851388 EUDAMED06430033852224 EUDAMED06430033852200 EUDAMED06430033851067 EUDAMED06430033851371 EUDAMED
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMEDLithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iCare HOME2 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211355 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 643003385TA023XC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (9)
- EUDAMED 31fa7d1f-e8e9-4cae-817c-e6f1bc6b5980 61 fields · synced Aug 1, 2026
- EUDAMED 18d72c36-afb4-4952-9c45-13eb1b3c7042 61 fields · synced May 11, 2026
- EUDAMED 6aa41202-ae01-4b7b-90e6-1553a8786461 61 fields · synced May 16, 2026
- EUDAMED 0838f494-9e3f-4919-989a-b4b4e65cac23 61 fields · synced May 17, 2026
- EUDAMED 486323e2-8d75-42d0-b0e8-a4c3e7416728 61 fields · synced May 17, 2026
- EUDAMED 732aa8a3-8bad-4930-b9b0-aa7c41130f4e 61 fields · synced May 18, 2026
- EUDAMED c96de2ea-2f3f-48c2-8520-ef7f3e3c1296 61 fields · synced May 18, 2026
- EUDAMED 19a9542e-dfe5-4ca5-baee-2d0794270527 61 fields · synced Jul 31, 2026
- FDA 510(k) K211355 1 fields · synced May 18, 2026