HarmonyAIR
The HarmonyAIR Mobile Stand with G-Series Lighthead with metal crate is designed to provide a flexible, mobile lighting system for various surgical and diagnostic procedures in healthcare…
The HarmonyAIR Mobile Stand with G-Series Lighthead with metal crate is designed to provide a flexible, mobile lighting system for various surgical and diagnostic procedures in healthcare environments.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | FSS |
| Device type | Light, Surgical, Floor Standing |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-19 |
| Record revised | 2025-01-28 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-01-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A-Series Mobile Light | In distribution | |
| A-Series Mobile Light | In distribution | |
| E-Series | Withdrawn | |
| M5 Mobile Surgical Light | Withdrawn | |
| G5 Mobile Surgical Light | Withdrawn | |
| M5 Mobile Surgical Light | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maquet Rolite | Maquet Gmbh | 35 |
| StarTrol | Huot Instruments, LLC | 9 |
| Aesculap | Aesculap AG | 5 |
| Lucea LED® | Maquet Gmbh | 4 |
| Amtai | Amtai Medical Equipment, Inc. | 4 |
| Nico Myriad-LX | Nico Corporation | 3 |
| Sunoptic Technologies | Sunoptic Technologies, LLC | 3 |
| Aurora Surgical Light Series | Skytron, LLC | 2 |
| Maxx Luxx LED 160 | Avante | 2 |
| MS Sim.LED OpL wDB | S.i.m.e.o.n. Medical GMBH & Co.KG | 2 |
| STARLED3 NX | Acem SPA | 2 |
| Nico Myriad-LX | Sunoptic Technologies, LLC | 2 |
Showing 12 of 37. All products under Light, Surgical, Floor Standing
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.