Rotixa 500 RS
Floor standing centrifuge for preparation of cell concentrate and/or plasma concentrate
5manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Hunan (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Hunan Xiang YI Laboratory Instrument Development Co., Ltd. | Changsha | Hunan | Manufacturer | 7 |
| Dlab Scientific Co., Ltd. | Shunyi District | Beijing | Manufacturer | 4 |
| Zhuhai Longtime Biological Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 4 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Andreas Hettich Gmbh, Germany |
|---|---|
| FDA product code | QBV |
| Device type | Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-09-02 |
| Record revised | 2026-01-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ROTIXA 500, Standard, N2 | In distribution | |
| ROTIXA 500, Standard, Heat/Cool | In distribution | |
| ROTIXA 500, Standard, Heat/Cool | In distribution | |
| ROTIXA 500, Standard | In distribution | |
| ROTIXA 500, Standard | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PDQ Platelet Centrifuge | Bio/Data Corp. | 1 |
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.