FDA device listing
Allevy Glucose Control Solution,Allevy MM1100 Blood Glucose Meter,Allevy MM1100 Blood Glucose Monitoring System,Allevy…
FDA device listing 1709714348 · TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
Key facts
| Proprietary names | Allevy Glucose Control Solution,Allevy MM1100 Blood Glucose Meter,Allevy MM1100 Blood Glucose Monitoring System,Allevy MM1100 Blood Glucose Test Strip,CareLiving Glucose Control Solution,CareLiving MM1100 Blood Glucose Meter,CareLiving MM1100 Blood Glucose Monitoring System,CareLiving MM1100 Blood Gucose Test Strip,CareTouch Blood Glucose Monitoring System,CareTouch Blood Glucose Test… |
|---|---|
| Owner/operator | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
| Owner/operator number | 9047576 |
| Premarket submissions | K111456 |
| Product codes | CGA, JJX, NBW |
| Device names | CGA - Glucose Oxidase, Glucose, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), NBW - System, Test, Blood Glucose, Over The Counter |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1345, 862.1660 |
| Review panels | Clinical Chemistry |
| Registered establishments | TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
| Establishment registrations | 9616530 |
| FEI numbers | 3003116995 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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