Checkpoint
Disposable breath alcohol test
16manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (2), Hunan (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dong Guan EEK Electronic Technology Co., Limited | Dong Guan | Guangdong | Contract manufacturer | 2 |
| Fujian Ruili Electronics Co., Ltd. | Ningde | Fujian | Contract manufacturer | 2 |
| Huizhou Maxway Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 2 |
| Hanwei Electronics Group Corporation | Zhengzhou | Henan | Contract manufacturer | 1 |
| Sunton Electronics Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 1 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Changsha U DE Toptech Electronic Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 3 |
| E-Business International Inc. | Shenzhen | Guangdong | Exporter | 2 |
| Rayco Electronic Ltd. | Dong Guan | Guangdong | Manufacturer | 2 |
| Shenzhen Well Electric Co., Limited | Shenzhen | Guangdong | Manufacturer | 2 |
Showing 12 of 16. All 16 manufacturers in China registered for Devices, Breath Trapping, Alcohol
Record
| Listed by | AlcoPro Inc, United States |
|---|---|
| FDA product code | DJZ |
| Device type | Devices, Breath Trapping, Alcohol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3050 |
| Establishment | Manufacturer |
| 510(k) | K102225 |
| Record published | 2022-09-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Packaging | Pack of 50, pack of 100, pack of 500 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CP08 | 25 | In distribution | |
| CP04 | 100 | In distribution | |
| CP02 | 100 | In distribution | |
| CP02 | 25 | In distribution | |
| CP04 | 25 | In distribution | |
| CP08 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Soberlink | Soberlink Healthcare LLC | 7 |
| AlcoBreath Tube | AlcoPro Inc | 4 |
| co-innovation | Co-Innovation Biotech Co., Ltd. | 1 |
| Easy@Home Fuel Cell Breathalyzer | Easy Healthcare Corporation | 1 |
| Accutest Breath Alcohol Detector | Jant Pharmacal Corp. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102225 | 2011-04-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.