FDA device listing
GCell Device; GCell Kit Large; GCell Kit Small; GCell Kit Transparent
FDA device listing 1968294901 · GLOBAL BIYOMEDIKAL SAGLIK HIZMETLERI SANAYI VE TICARET LIMIT
Key facts
| Proprietary names | GCell Device; GCell Kit Large; GCell Kit Small; GCell Kit Transparent |
|---|---|
| Owner/operator | GLOBAL BIYOMEDIKAL SAGLIK HIZMETLERI SANAYI VE TICARET LIMIT |
| Owner/operator number | 10085810 |
| Product codes | KET |
| Device names | KET - Filters, Cell Collection, Tissue Processing |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3010 |
| Review panels | Pathology |
| Registered establishments | GLOBAL BIYOMEDIKAL SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI |
| Establishment registrations | 3022177334 |
| FEI numbers | 3022177334 |
| 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