Identity
- Trade Name
- iCare PATIENT2 EUDAMEDFDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- iCare PATIENT2 EUDAMEDiCare PATIENT2 (iOS version) FDA UDI
- Model / Reference
- TS05 EUDAMEDFDA UDI
- Description
- iCare PATIENT2 (iOS version) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430033851098 EUDAMEDFDA UDI
- Basic UDI-DI
- 643003385TS057X EUDAMED
- 510(k) Number
- K211355 FDA UDI
- FDA Product Code
- HKY FDA UDI
- EMDN Code
- Z12120182 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iCare PATIENT2 by Icare Finland Oy — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 643003385TS057X | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (2)
- EUDAMED a37e2f0a-b0da-4e0c-ad93-10845595ad5b 61 fields · synced Jul 9, 2026
- FDA UDI f76dda2b-c606-4947-9273-b65d4c10d863 34 fields · synced May 30, 2026