Identity
- Trade Name
- iCare TA01i EUDAMEDFDA UDI
- Generic Name
- Ophthalmic tonometer, battery-operated FDA UDI
- Device Name
- iCare TA01i EUDAMEDThe Icare tonometer is used in the diagnosis, follow up and screening of glaucoma. It is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic. The Icare tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye. FDA UDI
- Model / Reference
- TA01i EUDAMEDFDA UDI
- Description
- The Icare tonometer is used in the diagnosis, follow up and screening of glaucoma. It is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic. The Icare tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430033850053 EUDAMED06430033850060 FDA UDI
- Basic UDI-DI
- B-06430033850053 EUDAMED
- 510(k) Number
- K063873 FDA UDI
- FDA Product Code
- HKX FDA UDIHKY FDA UDI
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
- GMDN Term
- Ophthalmic tonometer, battery-operated FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- Not 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
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
iCare TA01i by Icare Finland Oy — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06430033850053 | 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 39afdb0f-ded7-43d6-a3ec-94b1bcb5ed13 61 fields · synced Jun 18, 2026
- FDA UDI fe3cd346-ba06-41ad-8e91-64faf1a8c6ed 35 fields · synced May 30, 2026