Data / Medical devices / Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate (QBV): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate (product code QBV, Class 1, 21 CFR 862.2050). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on April 2, 2026, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- QBV
- Device class
- 1
- Regulation
- 862.2050
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| South Korea | 2 |
| United States | 1 |
| Germany | 1 |
| India | 1 |
Makers of Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Miracell Co.,Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 2 | April 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Alira Medical Devices LLC | Rancho Cucamonga, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Andreas Hettich GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DLAB Scientific Co., Ltd. | Shunyi District Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hunan Xiang Yi Laboratory Instrument Development Co., Ltd | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Trausim Medical Instrument Co.,ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDIKAN CO., Ltd. | Gangseo-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai Longtime Biological Technology Co., Ltd. | Zhuhai City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.