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iCare IC100
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Standard A2Model TA011Ref Standard A (item 240EU)Ref Standard ARef Standard A1Model TA032
Identity
- Trade Name
- iCare IC100 EUDAMEDiCare IC1000 EUDAMED
- Device Name
- iCare IC100 EUDAMEDiCare IC1000 EUDAMED
- Model / Reference
- TA011 EUDAMEDStandard A2 EUDAMEDStandard A (item 240EU) EUDAMEDStandard A EUDAMEDTA032 EUDAMEDStandard A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033851814 EUDAMED06430033852170 EUDAMED06430033850466 EUDAMED06430033852576 EUDAMED
- Basic UDI-DI
- 643003385TA011X5 EUDAMED643003385TA032XD EUDAMED
- Direct Marketing DI
- 06430033851814 EUDAMED06430033852170 EUDAMED06430033850466 EUDAMED06430033852576 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 IC100 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 | K153694 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 643003385TA011X5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (5)
- EUDAMED 0ca129b7-9d9a-44e8-8ea7-85b74f78c857 61 fields · synced Sep 18, 2026
- EUDAMED cb737f84-dfd2-447b-81b4-67671a7055bb 61 fields · synced May 17, 2026
- EUDAMED 75fe9775-2072-4697-a0c7-2b58c9b61ce6 61 fields · synced May 18, 2026
- EUDAMED 2cd57cc5-fa8e-4ee4-b559-d9a47c0e1428 61 fields · synced Jul 8, 2026
- FDA 510(k) K153694 1 fields · synced May 18, 2026