Identity
- Trade Name
- iCare ST500 FDA UDI
- Generic Name
- Ophthalmic tonometer, battery-operated FDA UDI
- Device Name
- iCare ST500 tonometer FDA UDI
- Model / Reference
- TA04 FDA UDI
- Description
- iCare ST500 tonometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430033851883 FDA UDI
- 510(k) Number
- K241447 FDA UDI
- FDA Product Code
- HKX FDA UDIHKY FDA UDI
- GMDN Term
- Ophthalmic tonometer, battery-operated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Ophthalmic tonometer, battery-operated
iCare ST500 by Icare Finland Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer, battery-operated.
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- KOWA Applanation Tonometer HA-2 — Kowa Co. , Ltd. · Class II
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- JEDMED — JEDMED Instrument Company · Class II
- schiötz C tonometer, inclined scale, silver — Rudolf Riester GmbH & Co. KG · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Icare Finland Oy
Sources (1)
- FDA UDI 2321c9ee-2b49-4458-8301-1619def3b970 34 fields · synced May 30, 2026