FDA device listing
FLUSHMAX HEPES buffered cell culture Medium for use in ART KIT 1,IVFMAX Bicarbonate buffered cell culture medium for…
FDA device listing 1861115677 · YENI BIYOTEKNOLOJI ANONIM SIRKETI
Key facts
| Proprietary names | FLUSHMAX HEPES buffered cell culture Medium for use in ART KIT 1,IVFMAX Bicarbonate buffered cell culture medium for fertilization by IVF or ICSI,mHTFMAX HEPES buffered cell culture Medium for use in ART KIT 1 |
|---|---|
| Owner/operator | YENI BIYOTEKNOLOJI ANONIM SIRKETI |
| Owner/operator number | 10092522 |
| Product codes | KIT |
| Device names | KIT - Media And Components, Synthetic Cell And Tissue Culture |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.2220 |
| Review panels | Hematology |
| Registered establishments | YENI BIYOTEKNOLOJI ANONIM SIRKETI |
| Establishment registrations | 3035387168 |
| FEI numbers | 3035387168 |
| 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