FDA device listing
DM1000,DM1000 LED,DM2000,DM2000 LED,DM2500,DM3000,DM3000 LED,DMi1
FDA device listing 1954012587 · Leica Biosystems, division of Leica Microsystems, Inc.
Key facts
| Proprietary names | DM1000,DM1000 LED,DM2000,DM2000 LED,DM2500,DM3000,DM3000 LED,DMi1 |
|---|---|
| Owner/operator | Leica Biosystems, division of Leica Microsystems, Inc. |
| Owner/operator number | 10054155 |
| Product codes | IBK |
| Device names | IBK - Microscope, Fluorescence/U.V. |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3600 |
| Review panels | Pathology |
| Registered establishments | Leica Instruments (Shanghai) Co., Ltd. |
| Establishment registrations | 3006610913 |
| FEI numbers | 3006610913 |
| Establishment operations | Contract 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