Hariomed
8 catalogue numbers from IW-A1800D, listed by HUA YUE Medical Technology Co., Ltd., China, under Assisted Reproduction Laminar Flow Workstation. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
Record
| Listed by | HUA YUE Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | QKH |
| Device type | Assisted Reproduction Laminar Flow Workstation |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6120 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IW-A1800D | In distribution | |
| IW-A1350C | In distribution | |
| IW-A1800 | In distribution | |
| IW-A1800S | In distribution | |
| IW-A1800M | In distribution | |
| IW-A950 | In distribution | |
| IW-A1350A | In distribution | |
| IW-A1350S | In distribution |
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.