Rotanta 460
Catalogue number ROTANTA 460 R - 100V-127V/50-60Hz, listed by Andreas Hettich Gmbh, Germany, under Centrifuge, Blood-Bank For In Vitro Diagnostic Use. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (1), Hunan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | Jiangyan | Jiangsu | Contract manufacturer | 19 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Hunan Xiang YI Laboratory Instrument Development Co., Ltd. | Changsha | Hunan | Manufacturer | 7 |
| Zenith Lab (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Andreas Hettich Gmbh, Germany |
|---|---|
| FDA product code | KSO |
| Device type | Centrifuge, Blood-Bank For In Vitro Diagnostic Use |
| Device class | Class 1 |
| Regulation | 21 CFR 864.9275 |
| 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 |
|---|---|---|
| ROTANTA 460 R – 100V-127V/50-60Hz | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bucket | Andreas Hettich Gmbh | 62 |
| Thermo Scientific | Thermo Electron LED GmbH | 50 |
| Swing-out rotor | Andreas Hettich Gmbh | 11 |
| Angle rotor | Andreas Hettich Gmbh | 6 |
| Rotanta 460 RF | Andreas Hettich Gmbh | 2 |
| Thermo Scientific Sorvall Lynx | Thermo Electron LED GmbH | 2 |
| Drum rotor | Andreas Hettich Gmbh | 1 |
| Rotanta 460 RC | Andreas Hettich Gmbh | 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.