FDA device listing
BL-7,CryoCube Series,CryoShipper Series,CryoSystem Series,DI Series,Doble Series,ET Series,GP Series,MVE Series,SC…
FDA device listing 1558353106 · MVE Biological Solutions US LLC
Key facts
| Proprietary names | BL-7,CryoCube Series,CryoShipper Series,CryoSystem Series,DI Series,Doble Series,ET Series,GP Series,MVE Series,SC Series,Spectrum Series,Vapor Shipper Series,XC Series,YDH Series,YDS Series |
|---|---|
| Owner/operator | MVE Biological Solutions US LLC |
| Owner/operator number | 10091790 |
| Product codes | KSP |
| Device names | KSP - Apparatus, Cell-Freezing And Reagents |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.9225 |
| Review panels | Hematology |
| Registered establishments | MVE BIOLOGICAL SOLUTIONS US LLC, MVE Cryogenic Biological Equipment (Chengdu) Co., Ltd |
| Establishment registrations | 3000184820, 3033918993 |
| FEI numbers | 3000184820, 3033918993 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database