Data / Medical devices / Chamber, Environmental For The Storage Of Platelet Concentrate
Chamber, Environmental For The Storage Of Platelet Concentrate (KSH): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Chamber, Environmental For The Storage Of Platelet Concentrate (product code KSH, Class 2, 21 CFR 864.9575). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSH
- Device class
- 2
- Regulation
- 864.9575
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| India | 5 |
| United States | 2 |
| Turkey | 1 |
Makers of Chamber, Environmental For The Storage Of Platelet 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 |
|---|---|---|---|---|---|---|---|---|
| Boekel Scientific | Feasterville, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HELMER Inc. | Noblesville, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Itas G Pharma | Guwahati Assam, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuve Sanayi Malzemeleri Imalat Ve Ticaret A.S. | Ankara, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remi Elektrotechnik Ltd. | Dist. Palghar Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 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.