Identity
- Trade Name
- AIT-650 FDA UDI
- Generic Name
- Ophthalmic instrument table, line-powered FDA UDI
- Device Name
- AIT-650 INSTRUMENT TABLE-110/120 VOLT; AC-Powered Ophthalmic Instrument Table FDA UDI
- Model / Reference
- 25065-11-001 FDA UDI
- Description
- AIT-650 INSTRUMENT TABLE-110/120 VOLT; AC-Powered Ophthalmic Instrument Table FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852683007254 FDA UDI
- FDA Product Code
- HRJ FDA UDI
- GMDN Term
- Ophthalmic instrument table, line-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4855 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic instrument table, line-powered
Ait-650 by Topcon Healthcare, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic instrument table, line-powered.
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- TIANNUO / TNMED — Lianyungang Tiannuo Optical Instrument Co., Ltd. · Class I
- Ophthalmic Electric Table — MDT SP Z O O · Class I
- Ophthalmic Electric Table — MDT SP Z O O · Class I
- S4 OPTIK — Blue.S4 Inc · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Topcon Healthcare, Inc.
Sources (1)
- FDA UDI 9a01881a-fe5e-4546-b4c4-5d66948e3878 33 fields · synced May 30, 2026