Identity
- Trade Name
- iCare HOME2 EUDAMED
- Device Name
- iCare HOME2 EUDAMED
- Model / Reference
- TA023 EUDAMEDStandard A3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033851760 EUDAMED
- Basic UDI-DI
- 643003385TA023XC EUDAMED
- Direct Marketing DI
- 06430033851760 EUDAMED
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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 — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 643003385TA023XC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (1)
- EUDAMED 779ff942-444c-47d7-a29b-a622f5625a9a 61 fields · synced May 23, 2026