Identity
- Trade Name
- iCare TP022 Probes EUDAMEDProbes for HOME FDA UDI
- Generic Name
- Ophthalmic tonometer probe FDA UDI
- Device Name
- iCare TP022 Probes, 50 pcs/box EUDAMEDSales package 50pcs FDA UDI
- Model / Reference
- TP022 EUDAMEDFDA UDI
- Description
- Sales package 50pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16430033850623 EUDAMEDFDA UDI
- Basic UDI-DI
- B-16430033850623 EUDAMED
- FDA Product Code
- HKX FDA UDIHKY FDA UDI
- EMDN Code
- Z12120185 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Ophthalmic tonometer probe FDA UDI
Classification
- Device Class
- Class I 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
iCare TP022 Probes by Icare Finland Oy — Class I — 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-16430033850623 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Icare Finland Oy
- EUDAMED SRN
- FI-MF-000000501
Sources (2)
- EUDAMED bacf80a5-24f2-46af-b2a7-15d4ef5beca5 61 fields · synced Jun 19, 2026
- FDA UDI 2c468a2e-1dde-494e-8b55-3cbad84d0aa7 34 fields · synced May 30, 2026