Identity
- Trade Name
- STARLED3 NX FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- STARLED3 NX TROLLEY ABPS FDA UDI
- Model / Reference
- STARLED3 NX /TB FDA UDI
- Description
- STARLED3 NX TROLLEY ABPS FDA UDI
Identifiers
- Catalog Number
- 110604 FDA UDI
- Primary DI / UDI-DI
- 08050705890439 FDA UDI
- FDA Product Code
- FSS FDA UDI
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating room light
Starled3 Nx by Acem Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HarmonyAIR — STERIS CORPORATION · 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
- Acem Spa
Sources (1)
- FDA UDI 3d42061e-5acb-44f5-854e-853d0b37673f 34 fields · synced May 30, 2026