Starsleep
Catalogue number Mattress and bed deck cover, listed by Shanghai Charme Health Technology Co., Ltd., under Mattress And Bed Deck Cover (Medical Purposes). 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Hebei (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hebei Junlaole Medical Technology Co., Ltd. | Hengshui | Hebei | Manufacturer | 15 |
| QuantMed LifeTech (Shenzhen) Co., Ltd. | Shenzhencity | Guangdong | Manufacturer | 6 |
Record
| Listed by | Shanghai Charme Health Technology Co., Ltd. |
|---|---|
| FDA product code | QTV |
| Device type | Mattress And Bed Deck Cover (Medical Purposes) |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6190 |
| Premarket notification | Exempt |
| Record published | 2023-09-28 |
| Record revised | 2023-11-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2023-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Mattress and bed deck cover | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Soteria Bed Barrier | Trinity Guardion, Inc. | 36 |
| Soteria Mattress Barrier | Trinity Guardion, Inc. | 8 |
| Meridian | Drive DeVilbiss Healthcare | 6 |
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.