iCare HOME2
by Icare Finland Oy EUDAMED
Active
Ref 260A2Model TA023
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFI22/00000011 | Date5 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- FI22/00000011 Supplemented
Quality management system EU MDR
- Notified body
- SGS FIMKO OY 0598
- Issued
- 5 Jun 2026
- Expires
- 6 Oct 2030
- Reason
- Add device or group
Specification
- Model / Reference
- TA023, 260A2
- Primary DI / UDI-DI
- 06430033852200
- Basic UDI-DI
- 643003385TA023XC
- Direct Marketing DI
- 06430033852200
- EMDN Code
- Z12120122 Tonometers
- Device Class
- Class IIa
- Market of Registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000000501
Other devices from Icare Finland Oy
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No