FDA device listing
KardiaMobile System
FDA device listing 1179624635 · Tecan Group AG
Key facts
| Proprietary names | KardiaMobile System |
|---|---|
| Owner/operator | Tecan Group AG |
| Owner/operator number | 9050992 |
| Product codes | DPS, DXH, QDA |
| Device names | DPS - Electrocardiograph, DXH - Transmitters And Receivers, Electrocardiograph, Telephone, QDA - Electrocardiograph Software For Over-The-Counter Use |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2340, 870.2345, 870.2920 |
| Review panels | Cardiovascular |
| Registered establishments | TECAN CDMO SOLUTIONS PN SDN. BHD. |
| Establishment registrations | 3015134086 |
| FEI numbers | 3015134086 |
| 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