FDA device listing
Sterile Temperature Probe,Sterile temperature probe-W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0001QS…
FDA device listing 1587274129 · Shenzhen Med-Link Electronics Tech Co.,Ltd
Key facts
| Proprietary names | Sterile Temperature Probe,Sterile temperature probe-W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0001QS, W0001FS, W0001PS, W0001LS |
|---|---|
| Owner/operator | Shenzhen Med-Link Electronics Tech Co.,Ltd |
| Owner/operator number | 10030237 |
| Premarket submissions | K251160 |
| Product codes | FLL |
| Device names | FLL - Continuous Measurement Thermometer |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.2910 |
| Review panels | General Hospital |
| Registered establishments | SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD |
| Establishment registrations | 3006636961 |
| FEI numbers | 3006636961 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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