FDA device listing
97203 Finger Covers-LG 6/72, F414-436WM EQ First Aid Covers 6/24,F414-436WM1 EQ First Aid Covers 6/24,Flent's Finger…
FDA device listing 1228198949 · K-One MediTech Sdn. Bhd
Key facts
| Proprietary names | 97203 Finger Covers-LG 6/72, F414-436WM EQ First Aid Covers 6/24,F414-436WM1 EQ First Aid Covers 6/24,Flent's Finger Cover: F414-405, F414-436, 69626 |
|---|---|
| Owner/operator | K-One MediTech Sdn. Bhd |
| Owner/operator number | 10058595 |
| Product codes | NAD |
| Device names | NAD - Dressing, Wound, Occlusive |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4020 |
| Review panels | General & Plastic Surgery |
| Registered establishments | K-One MediTech Sdn. Bhd |
| Establishment registrations | 3014747754 |
| FEI numbers | 3014747754 |
| 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