FDA device listing
NANOLET
FDA device listing 1799402943 · SOYAGREENTEC CO.,LTD
Key facts
| Proprietary names | NANOLET |
|---|---|
| Owner/operator | SOYAGREENTEC CO.,LTD |
| Owner/operator number | 9062715 |
| Product codes | FMK |
| Device names | FMK - Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4850 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SOYAGREENTEC CO.,LTD |
| Establishment registrations | 3004525100 |
| FEI numbers | 3004525100 |
| Establishment operations | Contract Sterilizer |
| 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