Identity
- Trade Name
- Eli Ezer FDA UDI
- Generic Name
- Ophthalmic tonometer, line-powered FDA UDI
- Device Name
- Non-Contact Tonometer FDA UDI
- Model / Reference
- ETN-1800 FDA UDI
- Description
- Non-Contact Tonometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851158007706 FDA UDI
- 510(k) Number
- K180820 FDA UDI
- FDA Product Code
- HKX FDA UDI
- GMDN Term
- Ophthalmic tonometer, line-powered 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, line-powered
Eli Ezer by U.s. Ophthalmic, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer, line-powered.
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- NON-CONTACT TONOMETER — Tomey Corporation · Class II
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- WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · 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
- U.s. Ophthalmic, L.l.c.
Sources (1)
- FDA UDI 1181c039-24ca-487e-ae31-8ae610b2668f 34 fields · synced May 30, 2026