Identity
- Trade Name
- S4 OPTIK FDA UDI
- Generic Name
- Ophthalmic instrument table, line-powered FDA UDI
- Device Name
- Ophthalmic instrument tabletop with power-bar (legs not included) FDA UDI
- Model / Reference
- TA1INTT-2E FDA UDI
- Description
- Ophthalmic instrument tabletop with power-bar (legs not included) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628308210343 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
S4 Optik by Blue.S4 Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic instrument table, line-powered.
- Ophthalmic Electric Table — MDT SP Z O O · Class I
- Ophthalmic Electric Table — MDT SP Z O O · Class I
- Ophthalmic Electric Table — MDT SP Z O O · Class I
- 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
- AIT-W2 — Topcon Healthcare, Inc. · Class I
- AIT-16A — Topcon Healthcare, 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
- Blue.S4 Inc
Sources (1)
- FDA UDI b196dd7e-c17b-42e8-8345-4a4ee019a5df 33 fields · synced May 30, 2026