FDA device listing
ARveo 8,ARveo 8x,Leica M320 C12,Leica M320 F12,Leica M320 FP12,Leica M320 LW12,Leica M320 TC12,Leica M320 TP12,Leica…
FDA device listing 1960488439 · Leica Microsystems CMS GmbH
Key facts
| Proprietary names | ARveo 8,ARveo 8x,Leica M320 C12,Leica M320 F12,Leica M320 FP12,Leica M320 LW12,Leica M320 TC12,Leica M320 TP12,Leica M320 W12,Leica M525 F20,Leica M530 OHX,Leica Wireless Footswitch, 12 Functions,Leica Wireless Footswitch, 14 Functions,MyVeo,PROvido,Surgical Microscope Air Removal System (SMARS) |
|---|---|
| Owner/operator | Leica Microsystems CMS GmbH |
| Owner/operator number | 10054809 |
| Product codes | EPT |
| Device names | EPT - Microscope, Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4700 |
| Review panels | General & Plastic Surgery |
| Registered establishments | LEICA INSTRUMENTS (SINGAPORE) PTE LTD., LEICA MICROSYSTEMS (SCHWEIZ) AG |
| Establishment registrations | 1000204638, 3003974370 |
| FEI numbers | 1000204638, 3003974370 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| 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