Identity
- Trade Name
- iCare LINK EUDAMED
- Device Name
- iCare LINK EUDAMED
- Model / Reference
- TS01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033850534 EUDAMED
- Basic UDI-DI
- B-06430033850534 EUDAMED
- EMDN Code
- Z12120182 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iCare LINK by Icare Finland Oy — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06430033850534 | Class I | Active |
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Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (1)
- EUDAMED 3e885e8e-4902-4e88-9ae7-b92a9cbd19ab 61 fields · synced Jul 13, 2026