FDA device listing
Axiolab 5,AxioObserver,Axiovert 5,Axio Vert A1,Primostar 1,Primostar 3,Primo Star / Primo Star iLED
FDA device listing 1433564751 · Carl Zeiss Inc.
Key facts
| Proprietary names | Axiolab 5,AxioObserver,Axiovert 5,Axio Vert A1,Primostar 1,Primostar 3,Primo Star / Primo Star iLED |
|---|---|
| Owner/operator | Carl Zeiss Inc. |
| Owner/operator number | 2431026 |
| Product codes | MTX |
| Device names | MTX - Microscope And Microscope Accessories, Reproduction, Assisted |
| Device class | Class I |
| Classification regulations (21 CFR) | 884.6190 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | Carl Zeiss Microscopy, GmbH, Carl Zeiss Suzhou Co., Ltd. |
| Establishment registrations | 8010666, 3008564898 |
| FEI numbers | 3008564898, 3012769735 |
| 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