Identity
- Trade Name
- iCare HOME EUDAMED
- Device Name
- iCare HOME EUDAMED
- Model / Reference
- TA022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033850183 EUDAMED
- Basic UDI-DI
- B-06430033850183 EUDAMED
- 510(k) Number
- K200966 FDA 510(k)
- FDA Product Code
- HKY FDA 510(k)
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1930 FDA 510(k)
- Regulation Number
- 886.1930 FDA 510(k)
- Market of Registration
- Finland EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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 HOME by Icare Finland Oy — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06430033850183 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K200966 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06430033850183 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (2)
- EUDAMED 6d5e86bb-5bae-4359-839a-7e82c494e5d4 61 fields · synced Jun 20, 2026
- FDA 510(k) K200966 24 fields · synced May 18, 2026