FDA device listing
ACE XS,ACE XS Lite,AL8000Plus,ALCOSCAN,ALCOSCAN ADBs,ALCOSCAN AL1100,ALCOSCAN AL1100F,ALCOSCAN AL2500,ALCOSCAN…
FDA device listing 1133605556 · Sentech Korea Corp
Key facts
| Proprietary names | ACE XS,ACE XS Lite,AL8000Plus,ALCOSCAN,ALCOSCAN ADBs,ALCOSCAN AL1100,ALCOSCAN AL1100F,ALCOSCAN AL2500,ALCOSCAN AL2500Elite,ALCOSCAN AL3100,ALCOSCAN AL3200,ALCOSCAN AL4000,ALCOSCAN AL5500,ALCOSCAN AL6000,ALCOSCAN AL6000Lite,ALCOSCAN AL7000,ALCOSCAN AL7010,ALCOSCAN AL8000,Alcoscan AL8500,ALCOSCAN AL8800,ALCOSCAN AL8800BT,ALCOSCAN AL9000,ALCOSCAN AL9000Lite,ALCOSCAN AL9010,ALCOSCAN ALC-1,ALCOSCAN… |
|---|---|
| Owner/operator | Sentech Korea Corp |
| Owner/operator number | 9066277 |
| Product codes | DJZ |
| Device names | DJZ - Devices, Breath Trapping, Alcohol |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.3050 |
| Review panels | Clinical Toxicology |
| Registered establishments | SENTECH KOREA CORP. |
| Establishment registrations | 3003383868 |
| FEI numbers | 3003383868 |
| Establishment operations | 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