Identity
- Trade Name
- Tri Star FDA UDI
- Generic Name
- Mobile examination/treatment room light FDA UDI
- Model / Reference
- TS2035M-E FDA UDI
Identifiers
- Catalog Number
- TS2035M-E FDA UDI
- Primary DI / UDI-DI
- 00853538008310 FDA UDI
- FDA Product Code
- KZF FDA UDI
- GMDN Term
- Mobile examination/treatment room light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6320 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: Mobile examination/treatment room light
Tri Star by Sunnex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mobile examination/treatment room light.
- MI Product Line — Medical Illumination International, Inc · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
- StarTrol — HUOT INSTRUMENTS, LLC · Class II
- Aseptico — ASEPTICO, INC. · Class I
- MI Product Line — Medical Illumination International, Inc · Class I
- VistOR EX LED — Medical Illumination International, Inc · Class I
- MRI-Safe — AADCO MEDICAL, INC. · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sunnex, Inc.
Sources (1)
- FDA UDI 9b6ced35-a917-4f50-97ae-42b25d5988b6 35 fields · synced May 30, 2026