FDA device listing
FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System,FORA GTel Multi-Functional Monitoring…
FDA device listing 1957331169 · TAIDOC TECHNOLOGY CORPORATION
Key facts
| Proprietary names | FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System,FORA GTel Multi-Functional Monitoring System,Heartscare C1 Plus |
|---|---|
| Owner/operator | TAIDOC TECHNOLOGY CORPORATION |
| Owner/operator number | 9058384 |
| Premarket submissions | K201037 |
| Product codes | CHH, JIN, NBW |
| Device names | CHH - Enzymatic Esterase--Oxidase, Cholesterol, JIN - Nitroprusside, Ketones (Urinary, Non-Quant.), NBW - System, Test, Blood Glucose, Over The Counter |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1175, 862.1345, 862.1435 |
| Review panels | Clinical Chemistry |
| Registered establishments | TAIDOC TECHNOLOGY CORPORATION |
| Establishment registrations | 3004145393 |
| FEI numbers | 3004145393 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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