FDA device listing
BINOCULAR INDIRECT OPHTHALMOSCOPE: BIO200, BIO200PLUS, BIO200-D
FDA device listing 1353780050 · SUZHOU RAISH MEDITECH CO., LTD
Key facts
| Proprietary names | BINOCULAR INDIRECT OPHTHALMOSCOPE: BIO200, BIO200PLUS, BIO200-D |
|---|---|
| Owner/operator | SUZHOU RAISH MEDITECH CO., LTD |
| Owner/operator number | 10095630 |
| Product codes | HLI |
| Device names | HLI - Ophthalmoscope, Ac-Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 886.1570 |
| Review panels | Ophthalmic |
| Registered establishments | SUZHOU RAISH MEDITECH CO., LTD |
| Establishment registrations | 3027667933 |
| FEI numbers | 3027667933 |
| 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