Identity
- Trade Name
- iCare TP022 Probes EUDAMEDProbes for HOME FDA UDI
- Generic Name
- Ophthalmic tonometer probe FDA UDI
- Device Name
- iCare TP022 Probes, 20 pcs/box EUDAMEDiCare TP022 Probes EUDAMEDSales package 20pcs of TP022 probes FDA UDI
- Model / Reference
- TP022 EUDAMEDFDA UDI114 EUDAMED
- Description
- Sales package 20pcs of TP022 probes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430033850947 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430033850947 EUDAMED643003385TP0222N 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 IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- 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
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
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 — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06430033850947 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06430033850947 | 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 (3)
- EUDAMED 6cb48356-816f-4782-9344-dc7cc9c37162 61 fields · synced Jul 20, 2026
- EUDAMED a977b6d6-f61d-488a-92c2-2c0b56a2828a 61 fields · synced May 18, 2026
- FDA UDI edd9e493-ffc9-4863-84bd-0fbf08700ce3 33 fields · synced May 27, 2026