Identity
- Trade Name
- iCare HOME2 FDA UDI
- Generic Name
- Ophthalmic tonometer, battery-operated FDA UDI
- Model / Reference
- TA023 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430033851456 FDA UDI
- 510(k) Number
- K211355 FDA UDI
- FDA Product Code
- HKY 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 HOME2 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.
- schiötz C tonometer, inclined scale, gold — Rudolf Riester GmbH & Co. KG · Class II
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- schiötz A tonometer, straight scale, silver — Rudolf Riester GmbH & Co. KG · Class II
- VISIONIX — LUNEAU TECHNOLOGY OPERATIONS · Class II
- KOWA Applanation Tonometer HA-2 — Kowa Co. , Ltd. · Class II
- PASCAL — SMT Swiss Microtechnology AG · Class II
- 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 3441235d-f124-4569-823c-cb9efe114d04 33 fields · synced Jun 8, 2026