FDA device listing
continuous measurement thermometer - ThermoWorks WAND Cinical; ThermoWorks WAND Mini,Infrared Ear Thermometer, Model…
FDA device listing 1065102102 · RADIANT INNOVATION, INC.
Key facts
| Proprietary names | continuous measurement thermometer - ThermoWorks WAND Cinical; ThermoWorks WAND Mini,Infrared Ear Thermometer, Model: THP86JE, THP86JEU, THR96JE, THR86JE, TH809J, MDS9700,Non-contact Forehead Thermometer, Model: THD2FE, TH48FE, TH09F,Probe Cover: PC 7200, PC 840, MDSM3A7208058 |
|---|---|
| Owner/operator | RADIANT INNOVATION, INC. |
| Owner/operator number | 9045429 |
| Product codes | SDV |
| Device names | SDV - Clinical Electronic Thermometer |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.2910 |
| Review panels | General Hospital |
| Registered establishments | KUNSHAN RADIANT INNOVATION CO., LTD., RADIANT INNOVATION INC. |
| Establishment registrations | 9710548, 3004026659 |
| FEI numbers | 3003515005, 3005961978 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| 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