FDA device listing
Accu-Chek Safe-T-Pro Plus
FDA device listing 1204657848 · ASAHI POLYSLIDER COMPANY, LIMITED
Key facts
| Proprietary names | Accu-Chek Safe-T-Pro Plus |
|---|---|
| Owner/operator | ASAHI POLYSLIDER COMPANY, LIMITED |
| Owner/operator number | 10026630 |
| 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 | ASAHI POLYSLIDER COMPANY, LIMITED Okayama-Kuse Plant |
| Establishment registrations | 8031690 |
| FEI numbers | 1000600761 |
| 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