Identity
- Trade Name
- iCare TP01 Probes EUDAMED
- Device Name
- iCare TP01 Probes, 600 pcs/box EUDAMEDiCare TP01 Probes, 100 pcs/box EUDAMEDiCare TP01 Probes EUDAMED
- Model / Reference
- TP01 EUDAMED104 EUDAMED107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430033850992 EUDAMED06430033850541 EUDAMED06430033851005 EUDAMED
- Basic UDI-DI
- B-06430033850992 EUDAMEDB-06430033850541 EUDAMED643003385TP0178 EUDAMED
- EMDN Code
- Z12120185 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iCare TP01 Probes by Icare Finland Oy — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06430033850992 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06430033850992 | Class I | Active |
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Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (4)
- EUDAMED 257d1e19-799a-455b-93e8-bda876d63cfb 61 fields · synced Jul 26, 2026
- EUDAMED af7f621f-ec60-497a-b88c-3baeab5e2110 61 fields · synced May 17, 2026
- EUDAMED 01c46c5d-5987-485d-89e3-b6b60b0a2bcc 61 fields · synced May 18, 2026
- EUDAMED 8d924a3a-5833-4329-a87c-f8c5813fc5a6 61 fields · synced May 18, 2026