FDA device listing
Enzymatic Esterase--Oxidase, Cholesterol
FDA device listing 1610003415 · HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.
Key facts
| Owner/operator | HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. |
|---|---|
| Owner/operator number | 9058334 |
| Premarket submissions | K901900 |
| Product codes | CHH |
| Device names | CHH - Enzymatic Esterase--Oxidase, Cholesterol |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1175 |
| Review panels | Clinical Chemistry |
| Registered establishments | DONGGUAN BAO KANG DIAN ZI KE JI LIMITED, HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. |
| Establishment registrations | 3008959444, 3020978007 |
| FEI numbers | 3008959444, 3020978007 |
| Establishment operations | Contract Manufacturer, Foreign Exporter |
| 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