Identity
- Trade Name
- iCare IC200 EUDAMED
- Device Name
- iCare IC200 EUDAMED
- Model / Reference
- TA031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033850909 EUDAMED
- Basic UDI-DI
- 643003385TA031XB EUDAMED
- Direct Marketing DI
- 06430033850909 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 IC200 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 | 643003385TA031XB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (1)
- EUDAMED cefc4d45-6de9-4eb0-a4b3-e0a9aaa2a257 61 fields · synced May 22, 2026