Identity
- Trade Name
- CT210 Contact Tonometer FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Non-active, contact applanation tonometer intended to measure intraocular pressure of the eye. FDA UDI
- Model / Reference
- 12598 FDA UDI
- Description
- Non-active, contact applanation tonometer intended to measure intraocular pressure of the eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812559010221 FDA UDI
- 510(k) Number
- K000288 FDA UDI
- FDA Product Code
- HKY FDA UDI
- GMDN Term
- Ophthalmic tonometer, manual 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, manual
CT210 Contact Tonometer by Reichert Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer, manual.
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- KAT APPLANATION PRISM — KEELER LIMITED · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- LuxVision — U.S. OPHTHALMIC, L.L.C. · Class II
- Sklar® — Sklar Corporation · Class II
- Keeler Disposable Tonomate - BX 100 — KEELER LIMITED · Class II
- Ambler Surgical — Ambler Surgical, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reichert Inc.
Sources (1)
- FDA UDI 0485384d-97b9-44ba-9b14-e53aaeed1d1b 35 fields · synced May 30, 2026