FDA device listing
BLUE 400,KINEVO 900 and accessories,KINEVO 900 S,OPMI Lumera 300,OPMI PENTERO 800 and accessories,OPMI PENTERO 900 and…
FDA device listing 1589868823 · Carl Zeiss Meditec AG (Jena)
Key facts
| Proprietary names | BLUE 400,KINEVO 900 and accessories,KINEVO 900 S,OPMI Lumera 300,OPMI PENTERO 800 and accessories,OPMI PENTERO 900 and accessories,PENTERO 800 S,S100 / OPMI pico and accessories,S7 / OPMI PROergo and accessories,S7 / OPMI Sensera and accessories,TIVATO 700 and accessories |
|---|---|
| Owner/operator | Carl Zeiss Meditec AG (Jena) |
| Owner/operator number | 9053564 |
| Product codes | FSO |
| Device names | FSO - Microscope, Surgical, General & Plastic Surgery |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4700 |
| Review panels | General & Plastic Surgery |
| Registered establishments | CARL ZEISS MEDITEC AG (OBERKOCHEN), Carl Zeiss Meditec (Suzhou) Co., Ltd. |
| Establishment registrations | 9615010, 3032734659 |
| FEI numbers | 3003481798, 3032734659 |
| 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