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iCare ST500
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Standard A2Model TA04Ref 270Ref Standard A1
Identity
- Trade Name
- iCare ST500 EUDAMED
- Device Name
- iCare ST500 EUDAMED
- Model / Reference
- TA04 EUDAMEDStandard A2 EUDAMED270 EUDAMEDStandard A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033851876 EUDAMED06430033851913 EUDAMED06430033851616 EUDAMED
- Basic UDI-DI
- 643003385TA0453 EUDAMED
- Direct Marketing DI
- 06430033851876 EUDAMED06430033851913 EUDAMED06430033851616 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 ST500 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 | K241447 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 643003385TA0453 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (4)
- EUDAMED ff8a6a90-fbe4-45ce-9b65-b0f09942e933 61 fields · synced Jul 25, 2026
- EUDAMED bab5a88b-4c44-4f44-b3fc-3f0bb0e1348e 61 fields · synced May 16, 2026
- EUDAMED 568ee026-52a6-4089-9654-de6c40a9756d 61 fields · synced May 17, 2026
- FDA 510(k) K241447 1 fields · synced May 18, 2026